DENTIS CO., LTD.

FDA Device Registration & Listing · Daegu, KR · Registration 3007031098

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3007031098
FEI Number
3007031098
Entity Name
DENTIS CO., LTD.
City/State/Country
Daegu, KR
Establishment Address
99, Seongseoseo-ro, Dalseo-Gu, Daegu 42718, KR
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Dentis Co., Ltd. (Owner Number: 10025697)
Owner / Operator Contact Address
99, Seongseoseo-ro, Dalseo-gu, Daegu, KR-27 42718, KR
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Dentis Dental Implant System s-Clean Link Abutment s-Clean SQ-SL Implant System Mini s-Clean TiN Coating Abutments s-Clean SQ-SL Implant System Regular Dentis s-Clean Abutment Mini i-Clean Guide No Mount Driver (DIGNMS, DIGNML, DIGNRS, DIGNRL) I-FIX Angled Mount Adapter (DNAMB, DNAMS, DNAMA) SQ AXEL Step Drill (DSASTD2414, DSASTD3807, DSASTD3808, DSASTD3810, DSASTD3812, DSASTD3820, DSASTD4207, DSASTD4208) SQ AXEL Step Drill (DSASTD5014, DSASTD4614, DSASTD4214, DSASTD3814, DSASTD5412) Osteotome (DSSO35R, DSSO42R, DSSO35S, DSSO42S) s-Clean MU Angled Trial Pin (DSMUATP17, DSMUATP30, DSMUATPM17, DSMUATPM30, DSMUATPN17, DSMUATPN30) s-Clean MU Trial Pin (DSMUSTP, DSMUSTPM, DSMUSTPN) I-FIX Bone Profiler (DBPI40) Bone Tack Drill (DBTD08) Tapered Twist Drill (DTD4307, DTD4308, DTD4310, DTD4312, DTD4314) Straight Twist Drill (DTD2208TC, DTD2210TC, DTD2212TC, DTD2214TC) s-Clean OneQ No-mount Driver (DSNDSS, DSNDSL) i-Clean Excellent Abutment Driver (DESAD) Bone Screw Driver Tip for Hand Piece (DGBSDTH) Path Guide Pin for SQ Fixture (DSQPGPS, DSQPGPR) Bone packer (DTOCA-BP) SAVE Tap Drill (DTW55, DTW60, DTW65, DTW70) Crestal Stopper (DSSCS8, DSSCS9, DSSCS10, DSSCS11, DSSCS12) Sensor gauge (DTOCA-SG) e-Clean Pick-Up Impression Coping Guide Pin (DEGPM10, DEGPM15, DEGPM20) Spreading pin (DSP-01) Reamer (DSSR28, DSSR31, DSSR36, DSSR41) Simple Guide Cortical Drill (DSGCD) SQ Step Drill (DSQSTD5007, DSQSTD5008, DSQSTD3510, DSQSTD3512, DSQSTD3514) Stopper (DST-08, DST-09, DST-10, DST-11, DST-12) s-Clean ScanBody (DSSBNES, DSSBNS, DSSBNL, DSSBNEL, DSSBRES, DSSBRS, DSSBRL, DSSBREL) s-Clean Transfer Impression Coping (DSITNZS40SS, DSITNZS40LS, DSITNZ45SS, DSITNZ45LS) Drill (DNLBC-2, DNLBC-3, DNLBC-4, DNLBC-5) Reamer (DSD-RM23, DSD-RM28, DSD-RM33, DSD-RM37, DSSR28N, DSSR31N, DSSR36N, DSSR41N) Parallel Pin (DPP) Tapered Twist Drill (DTD4108TC, DTD4110TC, DTD4112TC, DTD4114TC) OneQ Straight Twist Drill (DOTD3107, DOTD3108, DOTD3110, DOTD3112, DOTD3114) SQ No-Mount Driver Regular Machine (DSQNDRMS, DSQNDRML) Stopper Support (DSS55, DSS60) SAVE SEPTUM DRILL KIT (DSSDK) Pro KIT (DPK) Stopper (DNLBC-ST2, DNLBC-ST3, DNLBC-ST4, DNLBC-ST5) s-Clean Pick-Up Impression Coping (DSIHS40SS, DSIHS40LS, DSIH40SS, DSIH40LS, DSIH45SS, DSIH45LS) Marking drill (DMD-3) Wrench adapter (DWA, DWA-01) s-Clean Pick-Up Impression Coping (DSIHZ55S, DSIHZ55L, DSIHZ65S, DSIHZ65L) Tapered Twist Drill (DTD5108, DTD5110, DTD5112, DTD5114) OneQ Straight Twist Drill (DOTD2507, DOTD2508, DOTD2510, DOTD2512, DOTD2514) SQ Guide Initial Drill (DSQGSTD3508, DSQGSTD4008, DSQGSTD4508, DSQGSTD5008) GT SMART KIT (DGNSK, DGENSK) Simple Guide Plus Driver for Machine (DSGPDA) Position Guide (DPG07) Tapered Twist Drill (DTD3708TC, DTD3710TC, DTD3712TC, DTD3714TC) Guide Wheel Initial Drill (DGWID20) Lateral Approach Reamer (DLAR-R8, DLAR-F8) s-Clean HI Bite Coping (DSHISC6520S, DSHISC6530S, DSHISC6540S, DSHISC6560S, DSHISC6580S) Tapered Twist Drill (DTD4107, DTD4108, DTD4110, DTD4112, DTD4114) s-Clean Transfer Impression Coping (DSITHZ55S, DSITHZ55L, DSITHZ65S, DSITHZ65L) Simple Guide Starter Drill (DSGSD2308) Universal Driver Handle (DGUDH, DOSUH) Pilot Drill (DGPD12) Guide Punch (DSDGTS-40, DSDGTS-50) Simple Guide Plus Initial Drill (DSGPID) Guide Wheel Guide Pole (DGWGP, DGWGPL) I-FIX Fixture Ratchet Driver (DMRL, DMRS) SAVE 02 (DSSS02) s-Clean Transfer Impression Coping (DSITHS40SS, DSITHS40LS, DSITH45SS, DSITH45LS) s-Clean Tapered Countersink (DSTCS37, DSTCS41, DSTCS43, DSTCS48) Straight Twist Drill (DTD2208, DTD2210, DTD2212, DTD2214) s-Clean HI Bite Coping (DSHISC4540BS, DSHISC4560BS, DSHISC4580BS) O-Ring Abutment Driver (DORADS, DORADL) Simple Guide Plus Reamer Drill (DSGPR45, DSGPR53) i-Clean Solid Abutment Driver (DSAD, DSADS, DSADL) Simple Guide Plus Sleeve Connector (DSGPSC) s-Clean HI Bite Coping (DSHISC5520S, DSHISC5530S, DSHISC5540S, DSHISC5560S, DSHISC5580S) Crestal Stopper (DSSCS3, DSSCS4, DSSCS5, DSSCS6, DSSCS7, DSSCS3N, DSSCS4N, DSSCS5N, DSSCS6N, DSSCS7N, DSSCS8N) Mini Depth Gauge (DMDP) i-Clean Transfer Impression Coping (DITIRS, DITIWS, DITINS, DITIWNS) i-Clean Shoulder Analog Pin (DISAPR) Impression Coping Guide Pin (DSGPZS15, DSGPZS19, DSGPZ15, DSGPZ19) SQ Guide Sleeve (DSQGS35, DSQGS45, DSQGS45C) Impression Coping Guide Pin (DSTSSZ, DSTSLZ, DSTSZ, DSTLZ) Surgical SQ KIT (DSQKN) TREPHINE KIT (DTREK) Lindemann Drill (DLIND23S, DLIND23L, DSSLD20, DLD-2, DSSLD20N) Lateral Approach Drill (DSSLAD60, DSSLAD80) Wrench (DSDWRH-00) Expander drill (DSDEXP-01, DSDEXP-02, DSDEXP-03, DSDEXP-04, DSDEXP-05) s-Clean Solid Type PS Abutment (DPSS6515, DPSS6525, DPSS6535, DPSA4515, DPSA4525, DPSA5515, DPSA5525) OneQ Countersink (DSOCS37, DSOCS39, DSOCS42, DSOCS47, DSOCS52, DSOCS60, DSOCS70, DSOCS80) s-Clean Transfer Impression Coping (DSITNS40SS, DSITNS40LS, DSITN45SS, DSITN45LS) SAVE BONE EXPANDING KIT (DSBEK) s-Clean OneQ KIT (DSOKIR-1) Orthodontic Handle Driver (DOSHD60) Aqua Tip (DSSAT, DSSAT31, DSSAT41) Parallel Pin for Drill (DPPD) s-Clean Transfer Impression Coping (DSITHS40S, DSITHS40L, DSITH45S, DSITH45L, DSITH55S, DSITH55L) i-Clean Plastic Cylinder (DIOPN, DIOPO) Guide Wheel KIT (DGWK) s-Clean Pick-Up Impression Coping (DSINZS40SS, DSINZS40LS, DSINZ40SS, DSINZ40LS, DSINZ45SS) SQ Guide KIT (DSQGK, DSQGKA) Tapered Twist Drill (DTD3508, DTD3510, DTD3512, DTD3514) Simple Guide Plus Straight Drill (DSGPSD3518, DSGPSD3520, DSGPSD3521) OneQ Straight Twist Drill (DOTD4207, DOTD4208, DOTD4210, DOTD4212, DOTD4214) i-Clean Transfer Impression Guide Pin (DITL, DITS) SQ Guide Initial Drill (DSQGSTD3510, DSQGSTD3512, DSQGSTD3514, DSQGSTD3516) Trephine drill (DTB-3) e-Clean Fixture Short Mount Screw (DESMS, DESRS, DESWS) Drilling Guide Wheel (DGW6, DGW7, DGW8, DGW9, DGW10, DGW12) SQ Guide Countersink (DSQGCS55) Tissue Punch (DSQGTP, DSDTIS-30, DSDTIS-35, DSDTIS-40, DSDTIS-45, DSDTIS-50) SAVE 03 (DSSS03, DSSS03N) SAVE RIDGE KIT (DSRK) s-Clean Pick-Up Impression Coping (DSINZ45LS, DSINZ55SS, DSINZ55LS, DSINZ65SS, DSINZ65LS) SQ KIT (DSQK, DSQAK) i-Clean Solid Abutment Plastic Coping (DISPB, DISWPB, DISPS, DISWPS) i-Clean SAVE Fixture Lab Analog (DILAS) i-Clean OneQ KIT (DIOK) SAVE Crestal KIT (DSCAK) SMART KIT (DNSK) Tissue Punch KIT (DTPK) e-Clean Fixture Lab Analog (DELAM, DELAR, DELAW) s-Clean MU Straight Abutment Digital Lap (DSMUSDL) Tapered Twist Drill (DTD4308TC, DTD4310TC, DTD4312TC, DTD4314TC) Simple Guide Intermediate Drill (DSGID2808) SQ Guide Initial Drill (DSQGSTD4510, DSQGSTD4512, DSQGSTD4514, DSQGSTD4516) Straight Twist Drill (DTD2808, DTD2810, DTD2812, DTD2814) Simple Guide Plus Straight Drill (DSGPSD4318, DSGPSD4320, DSGPSD4321) s-Clean Ratchet Driver (DRMDSS, DRMDSL, DRMDSEL, DSRDSS, DSRDSL) Simple Guide Plus Profiler Drill (DSGPPD) Bone Tack Removal Tip (DGBTRT) Torque Ratchet (DTR, DTR70) SQ Guide Initial Drill (DSQGSTD5010, DSQGSTD5012, DSQGSTD5014, DSQGSTD5016) Path Guide Pin for s-Clean Fixture (DSPGPS, DSPGPR) Top Bur (DH-2, DH-3, DL-2, DL-3) SAVE Twist Drill (DSD5508, DSD5512, DSD6008, DSD6012, DSD6508, DSD6512, DSD7008, DSD7012) SQ Guide Tissue Punch (DSGPTP) s-Clean MU Transfer Impression coping Screw (DSMUTICS) I-FIX Point Drill (DIPD) Orthodontic Ratchet Driver (DOSRD30) s-Clean MU Pick-up Impression Coping Screw (DSMUPICS) Tapered Twist Drill (DTD3508TC, DTD3510TC, DTD3512TC, DTD3514TC) e-Clean Fixture Mount (DEFMM, DEFMR, DEFMW) Probe Depth Gauge (DPDG) SAVE 01 (DSSS01) Straight Tap Drill (DSTR41, DSTW48) DENTIS GUIDE Anchor Screw (DGAS18) Bone Ridge Chisel (DBCA15, DBCA25) Mount Driver for Ratchet (DRHDS24, DRHDL24, DRHDS30, DRHDL30) s-Clean Pick-Up Impression Coping (DSINZS40S, DSINZS40L, DSINZ40S, DSINZ40L, DSINZ45S) SQ Guide No-Mount Driver (DSQGNDNMS, DSQGNDNML, DSQGNDNRS, DSQGNDNRL) Handpiece condenser (DSDADP-01) I-FIX Angled Type Impression Coping (DMIC12S, DMIC18S, DMIC23S) s-Clean MU Angled Abutment Digital Lap (DSMUADL17, DSMUADL30) SQ Countersink Wide (DSQCSW60, DSQCSW70, DSQCSW80) Simple Guide Analog Positioner (DSGAP, DSGAPS) s-Clean Pick-Up Impression Coping Guide Pin (DSGP11, DSGP15, DSGP19) s-Clean Pick-Up Impression Coping (DSIHZS40SS, DSIHZS40LS, DSIHZ40SS, DSIHZ40LS) Straight Twist Drill (DSTD3508, DSTD351C, DSTD3512, DSTD3514) s-Clean ScanBody (DSSBMES, DSSBMS, DSSBML, DSSBMEL) SQ Countersink Short (DSQCSS50) Tapered Twist Drill (DTD3707, DTD3708, DTD3710, DTD3712, DTD3714) Hex Driver for Ratchet (DRHDES125, DRHD3512) i, s-Clean tapered KIT (DIK, DGIK, DIKO) Simple Guide Plus Driver for Ratchet (DSGPRDA) Hex Driver for Ratchet (DRD09, DRD12S, DRD12L, DRD125S, DRD125L, DRHDL09, DRHDS125, DRHDL125) Tapered Twist Drill (DTD5108TC, DTD5110TC, DTD5112TC, DTD5114TC) s-Clean Transfer Impression Coping (DSITN55SS, DSITN55LS, DSITN65SS, DSITN65LS) MU Transfer Impression Coping (DMTICS) Mini Twist Drill (DMD13TC, DMD18TC, DMD23TC) s-Clean MU Pick-up Impression Coping (DSMUPIC, DSMUPICSS) Diamond Bur (DSSDB20L) Simple Guide Pilot Drill (DSGPD2210, DSGPD2212,DSGPD2214) OneQ Surgical Tap (DSOFST30, DSOFST33, DSOFST37, DSOFST42, DSOFST47, DSOFST52, DSOFST60, DSOFST70, DSOFST80) Simple Guide Plus Straight Drill (DSGPSD2016, DSGPSD2018, DSGPSD2019) Octa Abutment Driver (DOADS, DOADL) Bone Well (DSSBW) i-Clean Solid Type PS Abutment (DPIS40, DPIS55, DPIS70, DPIA15, DPIA25) Stopper (DST-03, DST-04, DST-05, DST-06, DST-07) i-Clean Excellent Solid Impression Cap (DIESICR, DIESICW) MU Pick-Up Impression Coping (DMPUICS) i-Clean OneQ KIT (DIOKU) e-Clean tapered KIT (DEK, DGEK) Tapered Twist Drill (DTD4807, DTD4808, DTD4810, DTD4812, DTD4814) SQ Step Drill (DSQSTD4010, DSQSTD4012, DSQSTD4014, DSQSTD4510, DSQSTD4512, DSQSTD4514) i-Clean No-mount Driver (DINDS, DINDL, DMMDI) SAVE Twist Drill (DSD5508TC, DSD5512TC, DSD6008TC, DSD6012TC, DSD6508TC, DSD6512TC, DSD7008TC, DSD7012TC) Cortical Perforation bur (DGCPB10L, DGCPB10H) I-FIX Fixture Machine Driver (DMML, DMMS) e-Clean Pick-Up Impression Coping Guide Pin (DEGPR10, DEGPR15, DEGPR20, DEGPW10, DEGPW15, DEGPW20) Simple Guide Plus Straight Drill (DSGPSD2818, DSGPSD2820, DSGPSD2821) Lateral Approach Drill (DLAD-6, DLAD-8) s-Clean Solid Type PS Abutment (DPSS4515, DPSS4525, DPSS4535, DPSS5515, DPSS5525, DPSS5535) Straight Twist Drill (DSTD4208, DSTD4210, DSTD4212, DSTD4214) OneQ Straight Twist Drill (DOTD2807, DOTD2808, DOTD2810, DOTD2812, DOTD2814) Bone Screw Driver (DGBSD) SINUS CURRETTES (DTOLA-01, DTOLA-02, DTOLA-03, DTOLA-04) Bone Tack Driver Straight (DGBTDS) i-Clean Excellent Solid Abutment Lab Analog (DIESLA30, DIESLA40, DIESLA55, DIESLA70) Simple Guide Sleeve (DSGS) s-Clean Pick-Up Impression Coping (DSIN45SS, DSIN45LS, DSIN55SS, DSIN55LS, DSIN65SS, DSIN65LS) SQ Guide Flattener (DSQGFD) Depth Gauge (DSSDG) i-Clean Solid Positioning Cylinder (DISIPCR, DISIPCW, DISIPCW65) s-Clean Plastic UCLA Abutment (DSPCH, DSPCN, DSPCHS, DSPCNS) MU Polishing Protector (DMPP) s-Clean Transfer Impression Coping (DSITNZ55SS, DSITNZ55LS, DSITNZ65SS, DSITNZ65LS) Restorative KIT (DRK) i-Clean Solid Abutment Lab Analog (DISLA30, DISLA40, DISLA55, DISLA70) e-Clean Plastic UCLA Abutment (DEPMH, DEPMN, DEPRH, DEPRN, DEPWH, DEPWN) s-Clean MU Straight Abutment Guide (DSMUSG) SQ Guide Initial Drill (DSQGSTD2208, DSQGSTD2210, DSQGSTD2212, DSQGSTD2214, DSQGSTD2216) SQ Guide Countersink (DSQGCS35, DSQGCS40, DSQGCS45, DSQGCS50) Guide Wheel Drill (DGWPDS, DGWPDL) i-Clean Ratchet Driver (DRMDIS, DRMDIL) s-Clean ScanBody Screw(DSSBSS, DSSBS) i-Clean Pick-Up Impression Coping (DIPINS, DIPIRS, DIPIS60S, DIPIWS, DIPIWNS) TOP-DRILL (DTD-3, DTD-4) s-Clean Transfer Impression Coping (DSITN45S, DSITN45L, DSITN55S, DSITN55L, DSITN65S, DSITN65L) s-Clean Digital Lab Analog (DSDLAN, DSDLAM, DSDLAR) Mini Twist Drill (DMD13, DMD18, DMD23) SQ Guide Initial Drill (DSQGSTD4010, DSQGSTD4012, DSQGSTD4014, DSQGSTD4016) e-Clean Transfer Impression Coping (DETIR60NS, DETIR60HS, DETIW60NS, DETIW60HS) Lateral Approach Reamer (DSSAR60, DSSAR80) Trephine Bur (DSDTRB-04, DSDTRB-05, DSDTRB-06, DSDTRB-07, DSDTRB-08) SQ Straight Twist Drill (DSQTD2807, DSQTD2808, DSQTD2810, DSQTD2812, DSQTD2814) Mount Driver for Machine (DMHD24, DMHD30, DMHDS24) Diamond reamer (DTOCA-DR20, DTOCA-DR28, DTOCA-DR33) i-Clean Octa Transfer Impression Coping (DIOTIS, DIOTIWNS, DIOTIOS, DIOTIWOS) Depth Gauge (DGAG-08, DSSDGN) s-Clean OneQ KIT (DSOKU) s-Clean HI Bite Coping (DSHISC4520S, DSHISC4530S, DSHISC4540S, DSHISC4560S, DSHISC4580S) Wall Expander (DSSWE) SAVE BONE CHIP DRILL KIT (DSBDK) s-Clean Pick-Up Impression Coping (DSIHZS40S, DSIHZS40L, DSIHZ40S, DSIHZ40L, DSIHZ45S, DSIHZ45L) s-Clean Pick-Up Impression Coping (DSINS40SS, DSINS40LS, DSIN40SS, DSIN40LS) Simple Guide KIT (DSGK) I-FIX Angled Type Mount Adapter (DMAMA) e-Clean Transfer Impression Coping (DETIM40NS, DETIM40HS, DETIR50NS, DETIR50HS) s-Clean Transfer Impression Coping (DSITHMZ40SS, DSITHMZ40LS, DSITHMZ45SS) Octa Abutment Lab Analog (DIOLA, DIOLAW) ZMD-1000B CLEAR-SG SAVE KIT (DSK, DGSK) s-Clean Impression Positioning Cylinder (DSIPC654, DSIPC655, DSIPC657) Path Guide Pin for SQ Fixture (DSQPGPM) Carbide Bur (DSSCB14L, DSSCB18L) e-Clean Pick-Up Impression Coping (DEIM40HS, DEIR50HS, DEIR60HS, DEIW60HS, DEIM40NS, DEIR50NS, DEIR60NS, DEIW60NS) e-Clean Fixture Short Mount (DEFMSM, DEFMSR, DEFMSW) s-Clean Transfer Impression Coping (DSITNZS40S, DSITNZS40L, DSITNZ45S, DSITNZ45L) Tapered Twist Drill (DTD4808TC, DTD4810TC, DTD4812TC, DTD4814TC) SQ Guide Initial Drill (DSQGID22, DSQGID35) DENTIS GUIDE Anchor Twist Drill (DGATD) Stopper (DGS03, DGS05, DGS07) SQ Guide Profile (DSQGPD35, DSQGPD40) Simple Guide Plus Sleeve (DSGPS) s-Clean ScanBody set (DSSBNESS, DSSBNSS, DSSBNLS, DSSBNELS, DSSBRESS, DSSBRSS, DSSBRLS, DSSBRELS) Expander drill (DSDEXPM-02, DSDEXPM-03, DSDEXPM-04, DSDEXPM-05) i-Clean Octa Pick-Up Impression Coping Guide Pin (DIOGP, DIOGP10, DIOGP15, DIOGP20) i-Clean Octa Pick-Up Impression Coping (DIOINS, DIOIWNS, DIOIOS, DIOIWOS) I-FIX Post Type Lab Analog (DMPL) s-Clean Digital Lab Analog (DSDLANS, DSDLAMS, DSDLARS) s-Clean Transfer Impression Coping (DSITHZS40SS, DSITHZS40LS, DSITHZ45SS, DSITHZ45LS) s-Clean Pick-Up Impression Coping (DSINMZ40SS, DSINMZ40LS, DSINMZ45SS) s-Clean MU Transfer Impression Coping (DSMUTIC, DSMUTICSS) s-Clean Pick-Up Impression Coping Guide Pin (DSGPS10, DSGPS14, DSGPS15, DSGPS19) Tapered Tap Drill (DTM35, DTM37, DTR41, DTR43, DTW48, DTW51) SQ Step Drill (DSQSTD5006, DSQSTD5010, DSQSTD5012, DSQSTD5014) Bone syringe (DBS-01) SAVE BONE TRIMMING KIT (DSBTK) SQ SINUS Guide Stopper (DSQSGS00, DSQSGS01, DSQSGS02, DSQSGS03) OneQ Smart KIT (DIOSK) i-Clean Solid Abutment Lab Analog (DISLAW40, DISLAW55, DISLAW70) s-Clean ScanBody Screw (DSSBSM) SQ Parallel Pin for Drill (DSQPP) Spreading adapter (DSA-01) I-FIX O-Ring Type Lab Analog (DMOL) O-Ring Abutment Lab Analog (DOLA) Straight KIT (DCSK) Combined KIT (DCK, DGCK) SAVE TORQUE (DSTDK) OneQ Straight Twist Drill (DOTD5307, DOTD5308, DOTD5310, DOTD5312) s-Clean Transfer Impression Coping (DSITNMZ45LS, DSITNMZ55SS, DSITNMZ55LS) SAVE GBR KIT (DGKT) SQ Countersink (DSQCS35, DSQCS40, DSQCS45, DSQCS50, DSQCS55, DSQCSS60) Orthodontic Engine Driver (DOSED22, DOSED32) Guide Drill (DGD-20) Step Drill (DSQSTD5507, DSQSTD5508, DSQSTD5510, DSQSTD5512, DSQSTD5514) Bone Tack Driver Curved (DGBTDC) s-Clean Pick-Up Impression Coping (DSIHZ45SS, DSIHZ45LS, DSIHZ55SS, DSIHZ55LS, DSIHZ65SS, DSIHZ65LS) s-Clean Transfer Impression Coping (DSITH65S, DSITH65L, DSITNS40S, DSITNS40L) OneQ Straight Twist Drill (DOTD6407, DOTD6408, DOTD6410, DOTD6412) SQ Lindemann Drill (DLINDST23) s-Clean Pick-Up Impression Coping (DSIH55SS, DSIH55LS, DSIH65SS, DSIH65LS) s-Clean Sole Abutment Plastic Coping (DSSP45S, DSSP48S, DSSP55S, DSSP60S, DSSP65S) i-Clean Solid Impression Cap (DISICR, DISICW, DISICW65 BMS Chisel (DSCL-05) s-Clean Transfer Impression Coping (DSITHZS40S, DSITHZS40L, DSITHZ45S, DSITHZ45L) SQ Guide Lindemann Drill (DSQGLD2204, DSQGLD2206, DSQGLD2210) SQ Step Drill (DSQSTD2814, DSQSTD3507, DSQSTD3508, DSQSTD4006, DSQSTD4007, DSQSTD4008, DSQSTD4507,DSQSTD4508,DSQSTD2820) SQ Straight Drill (DSQSD2206, DSQSD2207, DSQSD2208, DSQSD2210, DSQSD2212, DSQSD2214, DSQSD2220) Bone Trimming Bur (DGBTB50L, DGBTB50H) Lateral Approach Cutter (DLAC-6, DLAC-8) SAVE BONE MULTI KIT (DSBMK) Bone Chip (DGBC50) Guide Drill (DSDGDL-02) s-Clean OneQ KIT (DSOK) Mini KIT (DMK) Drill Extension (DDE) s-Clean Transfer Impression Coping (DSITH55SS, DSITH55LS, DSITH65SS, DSITH65LS) e-Clean Transfer Impression Guide Pin (DETSM, DETSR, DETSW) Depth Gauge (DDG22, DDG28) Straight Twist Drill (DTD2808TC, DTD2810TC, DTD2812TC, DTD2814TC) OneQ Straight Twist Drill (DOTD3607, DOTD3608, DOTD3610, DOTD3612, DOTD3614) SQ Guide No-Mount Driver (DSQGNDRMS, DSQGNDRML, DSQGNDRRS, DSQGNDRRL) s-Clean Impression Positioning Cylinder (DSIPC454, DSIPC455, DSIPC457) Titanium Suction Tip (DSSST) Stopper (DS55-2, DS55-3, DS55-4, DS60-2, DS60-3, DS60-4) s-Clean Transfer Impression Coping(DSITNZ55S, DSITNZ55L, DSITNZ65S, DSITNZ65L) ZMD-1000B Model Saw Disk (DSDSAW-07, DSDSAW-09, DSDSAW-14) Simple Guide Plus Straight Drill (DSGPSD2024, DSGPSD2824) Ratchet Wrench (DRW) s-Clean Pick-Up Impression Coping (DSINZ45L, DSINZ55S, DSINZ55L, DSINZ65S, DSINZ65L) s-Clean MU Angled Abutment Guide (DSMUAG) Point Drill (DPD) SAVE SINUS KIT (DSSK) SQ No-Mount Driver Regular Ratchet (DSQNDRRS, DSQNDRRL) SINUS KIT (DSINK) Bone pusher (DNLBC-BP) s-Clean Pick-Up Impression Coping (DSINMZ45LS, DSINMZ55SS, DSINMZ55LS) SQ SHORT&WIDE KIT (DSQSWK) Bone packer (DSSBP, DSSBPN) Guide Wheel Guide Pin (DGWGP6, DGWGP7, DGWGP8, DGWGP9, DGWGP10, DGWGP12) s-Clean Fixture Lab Analog (DSCLA, DSCALS) I-FIX Angled Type Mount Adapter Screw (DMAMS) s-Clean Impression Positioning Cylinder (DSIPC554, DSIPC555, DSIPC557) Lateral Stopper (DSSLS05, DSSLS10, DSSLS15, DSSLS20, DSSLS25, DSSLS30) ZMD-1000B Castable SAVE BONE SPREADING KIT (DSBSK) MU Lab Analog (DMLA) s-Clean Transfer Impression Coping (DSITHZ55SS, DSITHZ55LS, DSITHZ65SS, DSITHZ65LS) Simple Guide Plus KIT (DSGPK) s-Clean Multi Use Coping (DSMUC5524S, DSMUC5534S, DSMUC5544S, DSMUC5564S, DSMUC5584S) SAVE Lateral KIT (DSLAK) Straight Mini KIT (DSMK) SAVE BASIC KIT (DSBISK) Surgical SQ KIT (DSQKF, DSQKN-1) s-Clean Multi Use Coping Transfer Impression Cap (DSHITIC) s-Clean ScanBody (DSSBMESS, DSSBMSS, DSSBMLS, DSSBMELS) s-Clean Sole Abutment Lab Analog (DSSLA554, DSSLA55, DSSLA557, DSSLA60L, DSSLA654, DSSLA65, DSSLA657) SQ SINUS Guide Initial Drill (DSQSGID2206, DSQSGID2210) i-Clean ScanBody (DISBSS, DISBLS, DISBWSS, DISBWLS) s-Clean OneQ SMART KIT (DSOSK) SPLIT MASTER KIT (DSPLMK) DOS KIT (DOSK) s-Clean Sole Abutment Lab Analog (DSSLA454, DSSLA45, DSSLA457, DSSLA48L) SQ Guide Step Drill (DSQGSTD5508, DSQGSTD5510, DSQGSTD5512, DSQGSTD5514, DSQGSTD5516) s-Clean Ratchet Driver Square Narrow (DSRDNS, DSRDNL, DSRDNEL) s-Clean Ratchet Driver Square Mini (DSRDMS, DSRDML, DSRDMEL) Straight Twist Drill (DSTD4208TC, DSTD4210TC, DSTD4212TC, DSTD4214TC) s-Clean Impression Positioning Cylinder (DSIPC45, DSIPC48, DSIPC55, DSIPC60, DSIPC65) i-Clean Shoulder Analog (DIISAR, DIISAW65) s-Clean Pick-Up Impression Coping (DSIHMZ45LS, DSIHMZ55SS, DSIHMZ55LS) Straight Twist Drill (DSTD3508TC, DSTD3510TC, DSTD3512TC, DSTD3514TC) i-Clean Excellent Solid Positioning Cylinder (DIESIPCR, DIESIPCW) s-Clean Sole Abutment Plastic Coping (DSSP45B, DSSP48B, DSSP55B, DSSP60B, DSSP65B) s-Clean Sole Abutment Lab Analog (DSSLAS404, DSSLAS405, DSSLAS407) i-Clean Fixture Lab Analog (DILA, DILAW) BONE PROFILER KIT (DBPK) s-Clean Impression Positioning Cylinder (DSIPCS404, DSIPCS405, DSIPCS407) s-Clean Ratchet Driver Square Regular (DSRDRS, DSRDRL, DSRDREL) s-Clean Transfer Impression Coping (DSITNMZ40SS, DSITNMZ40LS, DSITNMZ45SS) I-FIX Angled Type Lab Analog (DMAL) SQ SINUS Guide SINUS Drill (DSQSGSD4107, DSQSGSD4111) SQ Guide No-Mount Driver (DSQGNDMMS, DSQGNDMML, DSQGNDMRS, DSQGNDMRL) s-Clean MU Straight Abutment Driver (DSMUSD) s-Clean Ratchet Driver (DRMDSMS, DRMDSML,DRMDSMEL) s-Clean Pick-Up Impression Coping (DSIHMZ40SS, DSIHMZ40LS, DSIHMZ45SS) s-Clean No-Mount Driver (DSNDMS, DSNDML) SQ SINUS Guide Initial Drill (DSQSGID3006, DSQSGID3010) SQ SINUS Guide KIT (DSQSGK) s-Clean Multi Use Coping Driver (DHIHS, DHIHL) SQ SINUS Guide SINUS Drill (DSQSGSD3607, DSQSGSD3611) s-Clean Multi Use Coping (DSMUC4524S, DSMUC4534S, DSMUC4544S, DSMUC4564S, DSMUC4584S) s-Clean Lab Analog Screw (DDLAS) SQ SINUS Guide SINUS Drill (DSQSGSD3107, DSQSGSD3111) i-Clean ScanBody (DISBS, DISBL, DISBWS, DISBWL) s-Clean Lab Analog (DSCLAM, DSSLAM405, DSSLAM407) s-Clean Transfer Impression Coping (DSITHMZ45LS, DSITHMZ55SS, DSITHMZ55LS) SQ SINUS Guide Depth Gauge (DSQSGDG) SQ SINUS Guide Stopper (DSQSGS04, DSQSGS05, DSQSGS06) SQ SINUS Guide SINUS Drill (DSQSGSD2807, DSQSGSD2811) s-Clean Multi Use Coping (DSMUC6524S, DSMUC6534S, DSMUC6544S, DSMUC6564S, DSMUC6584S) Drill Holder (DDH39, DDH43, DDH53) Hex Driver for Ratchet (DRHDL12) s-Clean Multi Use Coping Bite Cap (DSHIBCS, DSHIBCL) s-Clean MU ScanBody (DSMUSBS, DSMUSBL, DSMUSBSS, DSMUSBLS, DSMUSBLF, DSMUSBLFS) SQ Mini Guide No Mount Driver (DSQMGNDMRS43.DSQMGNDMRL43) MU ScanBody Screw (DSMUSS) s-Clean Multi Use Coping Screw (DSHHS01, DSHHS02, DSHHS03, DSHHS04, DSHHS06, DSHHS08) SQ Mini Guide Step Drill (DSQMGSTD392208, DSQMGSTD392210, DSQMGSTD392212, DSQMGSTD392214, DSQMGSTD392216) I-FIX Post Type Temporary Cap (DMPTC) O-Ring Abutment O-Ring (DOAO100) MU Abutment Driver (DMAD) s-Clean Plastic UCLA Abutment (DSPCHM, DSPCNM, DSPCHMS, DSPCNMS) SQ Mini Guide Sleeve (DSQMGS4307, DSQMGS4305, DSQMGS3907, DSQMGS3905) ScanBody KIT (DSBK) SQ Mini Guide Step Drill (DSQMGSTD434008, DSQMGSTD434010, DSQMGSTD434012, DSQMGSTD434014, DSQMGSTD434016) s-Clean Multi Use Coping (DSMUCN4524 DSMUCN4534 DSMUCN4544 DSMUCN4564 DSMUCN4584) SQ Mini Guide No Mount Driver (DSQMGNDMRS39, DSQMGNDMRL39) Hex Driver for Ratchet (DRHDSO, DRHDLO) SQ Mini Guide Flattener (DSQMGFD39, DSQMGFD43) SQ Mini Guide Countersink (DSQMGCS3935, DSQMGCS4340) SQ Mini Guide Initial Drill (DSQMGID4304, DSQMGID4306, DSQMGID4310) Smart Drill (DSD3314TC, DSD3714TC, DSD3914TC, DSD4314TC) MU Reverse ScanBody (DSMURSBS, DSMURSB) I-FIX Post Type Impression Cap (DMPIC) s-Clean Multi Use Coping (DSMUCN4524S DSMUCN4534S DSMUCN4544S DSMUCN4564S DSMUCN4584S) SQ Guide Long Drill (DSQGLD) i-Clean Digital Lab Analog (DIDLAR, DIDLARS, DIDLAW, DIDLAWS) I-FIX Angled Type ScanBody Screw (DFSBS) Surgical SQ KIT (DSQKA) SQ Mini Guide No Mount Driver (DSQMGNDMMS39, DSQMGNDMML39) Straight Pilot Drill (DSPD28, DSPD35, DSPD42, DSPD47, DSPD57) SQ Mini Guide Profiler (DSQMGPD39, DSQMGPD43) s-Clean ScanBody (DSSBRLF, DSSBMLF, DSSBNLF) Surgical SQ KIT (DSQKAU) Simple Guide KIT (DSGKU) SQ Mini Guide Step Drill (DSQMGSTD393508, DSQMGSTD393510, DSQMGSTD393512, DSQMGSTD393514, DSQMGSTD393516) s-Clean MU Digital Lab (DSMUDL, DSMUDLS) SQ Mini Guide Tissue Punch (DSQMGTP39, DSQMGTP43) Digital Lab Analog Screw (DDLAWS) s-Clean Multi Use Coping Screw (DSMUCSN02 DSMUCSN03 DSMUCSN04 DSMUCSN06 DSMUCSN08) s-Clean Sole Abutment Plastic Coping (DSSASP40S, DSSASP40B, DSSAP45S, DSSAP45B) SQ Mini Guide Long Drill (DSQMGLD) SQ Mini Guide No Mount Driver (DSQMGNDMMS43, DSQMGNDMML43) I-FIX Angled Type ScanBody (DFASBLS, DFASBSS, DFASBL, DFASBS) MU Plastic Cylinder (DMPCS) s-Clean Fixture Lab Analog (DSCLA1) SQ Mini Guide KIT (DSQMGK, DSQMGKO) SQ Mini Guide Initial Drill (DSQMGID3904, DSQMGID3906, DSQMGID3910) Tissue Punch (DMTP30, DMTP40, DMTP50, DMTP55, DMTP60) SQ Step Drill (DSQSTD3520, DSQSTD4020, DSQSTD4520, DSQSTD5020, DSQSTD5520) i-Clean Plastic Cylinder (DIOPWO, DIOPWN) s-Clean ScanBody (DSSBRLFS, DSSBMLFS, DSSBNLFS) Hex Driver for Ratchet (DRHDS12, DRHD2312, DRHD23125, DRHD35125) Smart Drill (DSD3310TC, DSD3710TC, DSD3910TC, DSD4310TC) s-Clean Sole Abutment Plastic Coping (DSSAP55S, DSSAP55B, DSSAP65S, DSSAP65B) SQ Mini Guide Step Drill (DSQMGSTD433508, DSQMGSTD433510, DSQMGSTD433512, DSQMGSTD433514, DSQMGSTD433516) Hex Driver for Machine (DMDH125L, DMDH125S, DMDH12S) MU Reverse Screw (DSMURS) s-Clean No-mount Driver (DSNDS, DSNDL, DMMDS) ScanBody Screw Bar (DSSBSBQ, DSSBSBQ4, DSSBSBH, DSSBSBH4, DSSBSBC4, DSSBSBT4) i-Clean Neck Profiler (DINP48, DINP65) SQ Step Drill (DSQSTD5007W, DSQSTD5008W) AXEL AOX KIT (DSAAONK, DSAAOMK) SQ Guide Profiler Drill (DSQGPDM) SQ AXEL Step Drill (DSASTD5007, DSASTD5008, DSASTD5010, DSASTD5012, DSASTD5020, DSASTD2420) s-Clean Link Abutment ScanPost (DSSPNC451047S, DSSPNC452047S, DSSPNC453047S, DSSPMC451047S, DSSPMC452047S,DSSPMC453047S) s-Clean Link Abutment ScanPost (DSSPMC451047, DSSPMC452047, DSSPMC453047, DSSPRC451047S, DSSPRC452047S, DSSPRC453047S) SQ AXEL Step Drill (DSASTD4210, DSASTD4212, DSASTD4220, DSASTD4607, DSASTD4608, DSASTD4610, DSASTD4612, DSASTD4620) Bone Profiler Base (DBPBM, DBPBR, DBPBN) Bone Profiler (DBP45, DBP55, DBP65) SQ AXEL Countersink (DSACS50, DSACS38, DSACS42, DSACS46) s-Clean MU Parallel Pin (DSMUPPA17, DSMUPPA30) SQ AXEL KIT (DSAMLK, DSAMK, DSANK, DSANLK) s-Clean Link Abutment ScanPost (DSSPRC451047, DSSPRC452047, DSSPRC453047, DSSPNC451047, DSSPNC452047, DSSPNC453047) SAVE CRESTAL SINUS KIT (DSCSK) SQ AXEL Parallel Pin for Drill (DSAPP) s-Clean Pre-Milled Abutment Mini s-Clean Pre-Milled Abutment s-Clean OneQ-SL Narrow Implant System Dentis s-Clean s-Line Dentis Dental Implant System OneQ-SL s-Clean Implant System OneQ-SL Implant System ZMD-1000B TEMPORARY Dentis i-Clean System SAVE GBR Silfradent SRL Haptite Coating Implant System Mesheet SAVE GBR DENTIS DENTAL IMPLANT SYSTEM Dentis SQ-SL AXEL Fixture s-Clean Link Abutment Narrow Dentis Dental Implant System Dentis s-Clean SQ-SL Fixture MU System OneQ-SL s-Clean Implant System Dentis s-Clean SQ-SL Narrow Implant System s-Clean SQ-SL Implant System Mini LED Mouth Prop

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2015-07-27
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2015-07-27
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2016-06-22
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2023-01-16
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2021-03-18
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2021-03-18
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2017-12-06
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2020-02-04
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2020-02-04
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2022-06-16
NDP Accessories, Implant, Dental, Endosseous Dental Class 1 872.3980 2009-07-14
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2021-09-10
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2021-08-19
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2016-12-08
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2016-12-08
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2021-04-19
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2021-04-19
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2017-09-06
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2017-09-06
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2016-04-19
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2016-01-11
EBG Crown And Bridge, Temporary, Resin Dental Class 2 872.3770 2019-01-02
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2023-07-12
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2023-02-08
DZI Drill, Bone, Powered Dental Class 2 872.4120 2014-03-10
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2012-04-17
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2012-04-17
NXC Aligner, Sequential Dental Class 2 872.5470 2024-02-26
DZL Screw, Fixation, Intraosseous Dental Class 2 872.4880 2023-03-27
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2008-04-30
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2026-03-05
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2023-05-25
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2009-06-29
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2024-05-21
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2023-01-13
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2017-04-28
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2023-05-26
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2020-04-15
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2020-04-15
EIF Accessories, Retractor, Dental Dental Class 1 872.4565 2010-09-20

Official Correspondent

No official correspondent registered.

US Agent Details

April Lee Business: Withus Group Inc. Email: withus6664@gmail.com Phone: (909) 2749971

Related Public Records

Same Entity

Dentis Co., Ltd.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3036190511 Dentis Co.,Ltd Dong-gu Daegu, KR
3033509587 DENTIS MEDICAL DIVISION Dong-gu Daegu, KR
3010373494 DENTIS MEDICAL DIVISION Daegu, KR

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K241065 Dentis Co., Ltd. ChecQ (AC100) 2025-03-21
K211871 Faico Medical, LLC FAICO Dental Implant System and CAD/CAM Abutments 2021-11-18
K081806 Idi Biomedical, LLC IDI IMPLANT SYSTEM 2008-11-07
K120793 Z-Systems AG Z-LOOK3 EVO SLM 2012-12-21
K130140 Intra-Lock International INTRA-LOCK OP DENTAL IMPLANT 2013-08-01

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0007-2018 Implant Direct Sybron Manufacturing, LLC 2
Implant Direct Swish Duo-Grip Healing Collar, Length: 3mm, Platform: 4.8 mm, Rx only, Sterile Dental Implant component.
Z-0010-2020 Implant Direct Sybron Manufacturing, LLC 2
ImplantDirect simply RePlant Implant, size 4.3mmD x 13mmL, 4.3mmD Platform, REF 604313U, Rx, Sterile. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA.
Z-0017-2026 S.I.N. Implant System Ltda Rua Soldador Ocimar Guimaraes da Silva 421 Jardim Analia Franco Sao Paulo Brazil 2
IMPLANT EPIKUT PLUS MT16 3,5X10,0MM, REF: ILM 3510N; IMPLANT EPIKUT PLUS MT16 3.8X11.5MM, REF: ILM 3511N; IMPLANT EPIKUT PLUS MT16 3,5X13,0MM, REF: ILM 3513N; IMPLANT EPIKUT PLUS MT16 3,5X15,0MM, REF: ILM 3515N; IMPLANT EPIKUT PLUS MT16 3,8X10,0MM, REF: ILM 3810N; IMPLANT CM16 3,8 X 11MM, REF: ILM 3811N; IMPLANT EPIKUT PLUS MT16 3,8X15,0MM, REF: ILM 3815N; IMPLANT EPIKUT PLUS MT16 4,0X10,0MM, REF: ILM 4010N; IMPLANT EPIKUT PLUS MT16 4,0X11,5MM, REF: ILM 4011N; IMPLANT EPIKUT PLUS MT16 4,0X13,0MM, REF: ILM 4013N; IMP EPIKUT PLUS LONG MT16 4,0X20,0MM, RES: ILM 4020N; IMPLANT EPIKUT PLUS MT16 4,0X8,5MM, RES: ILM 4085N; IMPLANT EPIKUT PLUS MT16 4,5X13,0MM, REF: ILM 4513N; IMPLANT EPIKUT PLUS MT16 4,5X15,0MM, REF: ILM 4515N; IMPLANT EPIKUT PLUS MT16 4,5X8,5MM, REF: ILM 4585N; IMPLANT EPIKUT PLUS MT16 5,0X10,0MM, REF: ILM 5010N; IMPLANT EPIKUT PLUS MT16 5,0X11,5MM, REF: ILM 5011N; IMPLANT EPIKUT PLUS MT16 4,5X10,0MM, REF: ILM 4510N; IMPLANT EPIKUT PLUS MT16 5,0X13,0MM, RES: ILM 5013N; IMPLANT EPIKUT PLUS MT16 5,0X15,0MM, REF: ILM 5015N; IMPLANT EPIKUT PLUS MT16 5,0X8,5MM, REF: ILM 5085N; IMP EPIKUT PLUS LONG MT16 4,0X18,0MM, REF: ILM 4018N; IMP EPIKUT PLUS LONG MT16 3,8X18,0MM, REF: ILM 3818N; IMPLANT EPIKUT PLUS MT16 4,5X11,5MM, REF: ILM 4511N; IMPLANT EPIKUT MT16 4,5X15,0MM, REF: ILM 4515; IMPLANT EPIKUT MT16 4,5X8,5MM, REF: ILM 4585; IMPLANT EPIKUT MT16 3,8X13,0MM, REF: ILM 3813; IMPLANT EPIKUT MT16 3,8X15,0MM, REF: ILM 3815; IMPLANT EPIKUT MT16 5,0X8,5MM, REF: ILM 5085; IMPLANT EPIKUT MT16 3,8X11,5MM, REF: ILM 3811; IMPLANT EPIKUT PLUS MT16 3,8X20,0MM, REF: ILM 3820N; IMPLANT EPIKUT PLUS MT16 4,5X18,0MM, REF: ILM 4518N; IMPLANT UNITITE MORSE COMPACT 6.0X7MM, REF: UCMC 6007N
Z-0018-2020 Implant Direct Sybron Manufacturing, LLC 2
ImplantDirect Legacy 3 Implant, REF 855216, SBM implant assembly, 2mmD x 16mmL, 4.5mmD platform, Rx, Sterile. The mislabeled model/part number on the vial cap is 835216. The responsible firm on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA. - Product Usage:Implant Direct Sybron Manufacturing LLC s dental implant product line consists of one-piece and two-piece implants for one-stage or two-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework.
Z-0019-2020 Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel 2
Paltop Advanced Plus Dental Implant Dia 6.0mm L10mm Catalog Number: 20-70024P

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007031098. Last updated year: 2026. Please use registration number 3007031098 when referencing this establishment in official correspondence.
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