Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9616119

FEI Number

3001032747

Entity Name

OSUNG MND CO., LTD.

City/State/Country

Gimpo-si Gyeonggi, KR

Establishment Address

57, Hwanggeum-ro 109beon-gil, Yangchon-eup, Gimpo-si Gyeonggi 10048, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

OSUNG MND CO., LTD. (Owner Number: 10023032)

Owner / Operator Contact Address

57, Hwanggeum-ro 109beon-gil, Yangchon-eup, Gimpo-si, KR-41 10048, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

GRF EXD3CH EXD54-17H XP23-11 EXD11-12 EXD5W EXS96 XPG-12 2BPCP12 XPG-12B BPUNC15 3XP23-WHO 3IBPCP12 EXDK EXS6XL BPCP8 XP23-W-W BPCP12 XP23-8 BPCP11 2BPUNC15 2EXD5-8 EXS23W EXS6 BPWHO 2EXDG16 XP23-12 EXD17-23 2BPCP8 2EXD17-23 EXS23H 2EXD5W EXS3A BPCP2 XP23-WHO 3IBPCP2-12 BPW EXS6L BPW15 BPWB BPCP12N XP23-W BPCP10 XP23-12B EXD2 3IBPCP2 BPQ2N BPGF-W EXS54H EXD5H EXDG16 2EXD5H EXS3 RCP5-7 RCP10 RCP9-11 RCP1-3 RCP9 RCPGL1 RCP11 SN4SUS SN3SUSL SNKHS SNF25 SN4TI SNR40 SNC45 SNF20 SNKCS SN3SUS SN3TI SNF30 OGBH018 SMGC100 SMGC90 OGBH022 SMGC70 SM01 SM-01 SMGC80 OGPP OGPA EXC38-39 3EXC33L 3EXCL61-62 EXCL63-64 3EXCL63-64 3EXC32L 3EXC63-64 EXCE2 EXC65-66 EXCL65-66 3EXC17 3EXC18 3EXCL65-66 EXC63-64 3EXC31L 3EXC65-66 EXCL61-62 EXC31L EXC33L 3EXC38-39 EXCE1 EXC17 EXC18 EXC32L TITU6 TITU3 PR2-2R PRR256 KNO1-2 TITU2 TITU4 PRTU PRR258 PRRS3 TITU1 TNC100 KNK15-16 TITU5 PRM1 BOS-SIK HTK145 HTM130C HTK145C NHC130TC NH150TC-P NH160 NH160TC HTM120C NHC150TC NH160TC-P HTM130 RDCSET RDSET RDSTD2 RDC202 RDC210 RDC201 RDC204 RDC211 RDC2A RDC2 RDC207 RDC203 EXS3 2EXSTU17H 2EXD23H-7H EXD3-9H EXD11-12 2EXD3-9H EXDG16 2EXD54-17H 2EXDG16 EXS23H EXS9H 2EXD5H EXS3AH EXD3CH 2EXD17-23 2EXS3AH EXS3H 2EXS54H EXS6 EXDK EXD17-23 EXD5-8 EXD5W 2EXS3H EXS54H e-EXD5H EXDPR058 2EXD5W EXS6L 2EXS96 EXS6XL 2EXD5-8 EXS96 EXD2 2EXSFM EXD3-3A EXS23W EXSPR01 EXD5H EXSTU17H 2EXS9H 2EXS17W 2EXD3-3A EXS17W EXDPR05 EXS3A EXD54-17H EXD23H-7H MICSA07S MICSA13S MICSA08 MICSA10S MICSA10 MICSA13 MICSS08 MICSS13 MICSS10 SCMB130 SCTC115 SCD170 SCLSA115 SCGC130 SCT115 SCC105 SCLSS115 SCMB145 SCGS130 SCLC115 PHNS RTCRC 3GRM1 RTCPD1 GRM3 RTCPS1 RTAN20 RTCN10 RTSWSH RTLW7045 RTP30 RTCPD2 RTLW6540 RTLS GRM2 RTLAS GRM1 RTSWSS RTCN8 RTSWSM RTCPD3 RTCRL 3GRM2 RTCRM 3GRM3 RTLW8050 RTTG RTCPS2 RTP90-1 ML29 ML20 ML25 FBL023 TCM015F BL012EF2 FBL025F THB60 FBL019EF THB70 IS008F DCL014C IS011F DCM010C DCM009F TCM009F FBL019 FBL025 CISS013 TCL011 CIS013F RP015SF CIS012 DCL012EF TCL013C BL012C4 CIS016 TCL009F DCL014EF PSM019C FSM010F THB50 THB90 DCM014F TRL012F DCXL016F DCM016F THB80 THR60 DCM010F THB40 TRXL014F TRXL012F IS013F DCM014 TRL014F DCXXL014F TCM013F CISS016 TCL013F DCL010EF TRL010 BL012EF4 TRM010 BL012EF6 ND010 FBM014EF RP015EF FSM010 DCM012EF DCM010EF TRXL010C BXL014EF6 CRP019EF DCXL014F DCL010F DCXL018F TCM011 CRP019SF FSS009F ND010F FSS009C FBL019SF IM008F DCM014C DCM012F PSM019F GRL020 DCM014EF GRM020C FBL014EF THR50 IM011F DCM016C DCL016F DCL012F TRM014 BM012EF2 THB30 DCL014F TRL010F RCP200 CPTC135 RCA197 URCL87 URCL85 URCL84 URCM2-4 3URCL85C 3URCL87C URCM11 URCL86 URPR1-2 URCL85MD URCM9 3URCL86C URCL88 URCM10 2CSCOM13 3PF48-702 PFWDS2 2CSCT1 PFWDS3 2CSCT10 CSCT1 CSCOM1 CSCT8 3PFWDS2 PFIW3 2CSCOMKIT CSCOM2 CSF3 3CSCT6 CSCOM13 CSF2 3CSCT15 2CSCT6 3CSCOM13 CSCT7 2CSCOM11 2CSCOM2 PICH 2CSCT15 2CSCT8 PF48-702 CSAT6 CSCT10 PIS CSCOM3 3CSCT1 3CSCT8 CSCOM4 CSCT15 2CSAT6 CSCT6 2CSCOM1 3CSK01 CSCOM5 PF43-47 CSCOM11 CSF1W 2CSCOM3 3PFWDS3 CSCOMKIT 3CSK02 CSCOM6 3CSCOM11 3PF43-47 2CSCOM6 3PFIW3 2CSCT7 2CSCOM4 2CSCOM5 TSEXLL TBESL TBWZ6 TXASP TBEXLL TSELU TARP1 TARP2 TBWP1 TBWPB TBEZ8 TBWP3 TSEMU TARMU TBWSL TBWPZ6 TARPB TBELL TBOSU TARLU TXARO TBELU TARPA TARSU TBOMU TARML TBWXLL TBOLU TBWPA TSESU TBOZ6 TBWLL TARLL TBWLU TBWSU TBWPZ4 TSEZ8 TBEML TBOLL TBWP4 TSESL TBWMU TBWML TARZ10 TBOSL TBEXLU TBWP2 TSEML TBESU TSELL TARSL TBOML TSEXLU TBEMU TBWXLU TNC165 TNC100 RDPL1 GCP171 PLG0-1 PLGOR1 GCPS6 GCP170 PLGOR3 GCP113 GCP113N PLG1-2 FX150S FXX22 FXX67A FX301 FX53L FX17 FXX13 FX1 FX101 FXX17 FXX7C FX150 FXX2 FXX51C FX222 FX10S FX151 FXX29C FXX79 FXX7 FX300 FXX18 FX151S FXX33C FX53R FXX13C SP-002-122-PMK SP-014-160-PMK PW16 WLG1 LPC90S OGPM OGBH022 LPC90 OGBH018 PW21 DG1 GP2530 BSY47 BSC3539 IDH7-15N ARP1 BSY70 BEPD2 BTSHCO BSY35 S26-325 S24-325 DBKC-B GP3340 S26-345 ARR1 USSTA5 BWSUS1 RGCPD OCAKIT BSWDTS BEPD OLAKIT S30-345 DBKC-A IDH5-15N BSWDTL RGCP1 USETW DSTA16 RSC30 S35-395 BTSHC BTIDH09 ITA-01 NTTS1 CV3S CVCD89-92 CVCD3-6 CV3 CV74-75 CV76-77 HSA12-13 LSJAC30-33 CMGR1-2 3CGR3-4 ICGR1-2 CGR1-2 CMGR9-10 2CGR9-10 3LSK02 LS204SD USS1 ICGR7-8 CRGR13-14 3CGR7-8 ICGR5-6 CRGR1-2 2LSMS11-12 2LSH6-H7 CRGR3-4 3CGR13-14 3CRGR1-2 CGR17-18 LSMS1-2 2CLGR5-6 LSU15-30 2CGR1-2 2CLGR9-10 2LSJAC34-35 2LSH5-33 3CGR11-12 3CGR9-10 LS204S USEPS 3CGR17-18 ICGR11-12 2CLGR1-2 CGR11-12 CMGR7-8 HSL34-35 LSJAC31-32 CMGR13-14 CRGR5-6 3CRGR13-14 CGR3-4 CRGR7-8 3CRGR3-4 CGR5-6 HSO8-9 LSJAC34-35 2CLGR13-14 CMGR3-4 HSP56-57 LSMS11-12 2CLGR3-4 CRGR9-10 CGR7-8 LS204 3CGR5-6 ICGR13-14 CGR13-14 CRGR11-12 LSU15-33 2CGR13-14 2CMGR11-12 3CGR15-16 2CLGR11-12 3LSU15-33 CMGR5-6 Diagnostic&Supragingival Scaling CMGR11-12 CSZ CGR9-10 3CGR1-2 3CRGR11-12 CGR15-16 2CGR7-8 3LSK01 2CGR3-4 2CMGR3-4 3CRGR9-10 2LSMS1-2 2LSJAC30-33 USEA 2CGR15-16 2CMGR1-2 3CRGR5-6 USEP 2CGR17-18 2CMGR13-14 3CRGR7-8 LSSCM152 2CLGR7-8 2CGR5-6 2CMGR5-6 3LSJAC34-35 LSH5-33 2CGR11-12 2CMGR7-8 LSH6-H7 2LSJAC31-32 2CMGR9-10 LESY1 LEBE1 SRMA57 SR1S TP35 TPH35S TP50CJ TPI40 TPH40C TPH45S TPH50C TP40 RDPN1 TPH40S TPI40G TP50 TPI50G TP45 TP40CJ TPH45C TPH50S RDPN1P TPI50 TPH35C ACBA1 ORCRM ORCRL BSWDR1.3 BSWDR1.6 LLL26 LLS21 BEPDP13 LLL21 LLS26 BSWDR1 3ORWBP1 LCPKT2 LCPKT4 LCPKT3 L-PKT LCPKT1 LCPKT5 PDS1-2S FSH3-7 PDS9-10S FSH5-11 PDS3-4S BSF ST1 ST1-F STSBC-1 BSF-5P 3ELLD50K 3EL34S MXP6C 4ELL301 ISPKN152 3EL304W 3ELLR302 4ELLR302 EPPR3 EP16 ERHB13-14 EP20 ISSL4 3ELLR503 4EL5 EL32F 3EL73 3ELL501 4EL301 4ELLR503 EL5 3ELL302 3ERP1 3ELLR30K 4ELLR30K 4EL34S EPKN1 EP15 3ELL50K 4EL31F EP9H 4ERP2 EL74 3ELL503 4EL304W 4ERP1 EL73 ERP2 4ELL30K MXP75S 4ELL50K MXP3SC 4EL81 IS65785 4ELL302 ISSC1 EL41 3EL301A 3EL31F ERP1 3ELLR501 EP23 MXP6S IS6577SC5 4ELL502 4EL34 EPBUSER EP14 3ELL30K 3ERP3 4ELLR502 ISSLKIT 3ELLR50K 4EL52 EL34 EP24G 3EL74 MXP9C 4ELLD501 4ERP3 ISSC2 MXP9S 4ELLD502 EL301 MXP3C 4EL73 EL34S EP9 3EL81 MXP3S 4EL74 EL4 3EL301 3ELL301 ISSL1 MXP9SC 4ELLD503 EL301A 3EL41 3ELLD501 4EL32F EP9S EL81 3ELL502 4EL301A 4ELLR50K EL52 4ELL303 3ELLD502 3EL32F 3ELL303 3ERP2 4ELLR501 ISSL3 3ELLR502 4EL41 EL31F 3EL52 ISSL2 MXS1 4EL4 4ELLD50K EL304W 3EL5 MXP6SC 4ELL503 3ELLR301 4ELLR301 3EL4 3ELLR303 4ELLR303 ERP3 4ELL501 3ELLD503 3EL34 SNK30K SNF190 SN3STSL SNF178 SNF3D1 SN3STS SNF3D2 SNK25K SNK20K SNF123 SN4TI SNF30 SN4STS SNF2D SNF20 SN3TI SNF137 SNF25 SNFOKIT CF01 CFRT85 3RECDA RECR3SKIT 4RECDB 4RECDA 3RECDB CF02 CFP5 CG01 Bone tack (BTKIT) CGR12-13 2CUSYN15-16 CUYG7-8 CU4L-4R 2CUGF3 CGR11-14 CUSYN15-16M 2CUC13-14 CUC13-14 CUMC13S-14S 2CUMC13S-14S CUSYN15-16 CUSUB-0 2CU2L-2R CUGF3 2CUSYN15-16M CU2L-2R DMCS5 DMEM BDMHM DME2 DMSS5 DME5 DME3G DMAPA DME3 DMFSS4 DMBFL DMFEM DME4G BDMHLT DME1G DMDCS4 DMFCS4 DMFSS5 DMBFLT DMPM DMBFM DMDSS4 DMFCS5 DME1 DMPRA DMBFS DME4 BDMHS DME2G BDMHL DMCS4 DMCS3 DMFPM DMSS4 DMS39 DMPRP DMSS3 DME5G DME6G SRTD60H SRTD25 SRTVD15 SRTVD25 SRTD15 SRTD25H SRTVD60H 3PSTARTER SRTVD40 SRTD40H SRTSD40 SRTVD90H SRTD90H SRTVD90 SRTVD60 SRTD5P SRTD15H SRTD90 SRTDH5P SRTVD40H SRTD40 SRTD60 SRTSD15 SRTVD25H SRTVD15H PM1520 PM2030 PM2025 PLGWL1 O-DA614BP DA614GM O-DA614GM DA622GM O-DA622GM O-DA618GM O-DA618BP DA618GM O-DA622BP DA622BP DA618BP DA614BP ORWB4 ORWB3 ORWB1 LPC90 LPC170 SAC1 SBA18 SBA18T2 SAE1 GMIJ43 SAF1 SBA18T3 GMIJ48 SBA18T1 SAB1 SAA1 MT28 MT26 MT29 MT27 2MHC3 SHS MHS 2MHC2 SRTHD SHC 2MHC1 SH2S 2MHS1 MHC BSF-5P BSF 277 8379 023 238 830RL 012 001BR-31 215.10M1 237.12M1 197TR-21F 198TR-14 001 801 018 172APB-018 194.18F3 168.16M3 534.11M1 164.10F4 164.14M2S 108JSF-008 141SR-11 156.16M1 298 878K 014 299FO-11F 294.12M1 237.20EC1 237EX-26F 001ABR-019C 033.14EF1 199TR-25EF 197TR-20 199TR-11EF 194.16F6 194.18EC3 170TF-S31F 466.31F1 160TC-11C 164.10EF2 107.14M3 137.20EC1 277.21F1 284.16C1 238 830RL 018 255.14C1 215.20C1 237.12M3 198TR-26EF 001.14M1 172APB-018F 194.18F5 168.14M5 168.16M6 534.9F1 546 6847KR 016 164.10M2 164.16C2 141SR-13 159.10EF1 296 876K 012 298FO-22EF 237.32M1 257JFO-023 039ATP-035 194ASM-018 197TR-SS21 001.16M1 194.16EF1 194.16M4 171TF-21F 584.21F2 160TC-S21 107.10M1 109SF-31 137.14M1 141SR-13C 298FO-22F 237EX-20 277 379 023 039EX-12 220AEZ-020C 194ASM-018EF 198 6856 018 001.18M1 194.16M5 168.11M1S 584.21M1 161AFN-010EF 164.12EC2 107.10M2 109SF-41 137.16EC1 141SR-13EF 297 877K 014 289 878 014 294.14M2 294.18M1 257.23M2 019DI-41 194.20EF1 194ASM-018F 194.12M3 194.16EF5 168.21M1 170TF-43 584.16M1 160APC-014 167 8859 010 107.10M3 284.9M1 294.16EF5 255SOP-016C 257.32F1 237.14M3 194.23M1 173 848 016 194.14M2 168.16F1SS 168.18EF3 169TF-S41 584 959 018 584.18F1 DBGOK 164.7F1 168 845 014 277.23F1 284.16F1 294.14M4 294.21M1 298FO-22 243AFN-014F 255.16C1 237.14F3 294.18C2 198TR-S13 237.32F1 172APB-021EF 194.18M3 168.16EF2 168.17C1 257JFO-018 038 811 033 194ASM-016F 197TR-S21 168.21M2 194.16EC7 194.16M3 ZR137.14M1 171TF-21EF 584.21EC2 539.8F1 546 8847KR 016 160TC-26 107.10C4 109JSF-010 137.14F1 584.25F1 164.16F1 159.15EF1 294.20EC1 288 877 009 294.16M2 237.21EF1 257.18F2 257FO-27F 037.35F1 194.25M1 194.16C10 168.16M1S 170TF-31 171CD-59F 584.14F1 287 876 009 584.18M2 DBZIK 160TC-21 294.16M1 068.42M1 257 368 023 137.10M1 257FO-27 037.33M1 237.16M1 194.24M1 194.16C1 168.16M1 170TF-23 584.14EC1 584.18M1 DBMEK 160TC-11F 165 858 010 299 879K 014 068.42C1 284.10F2 237EX-21C 245.12F1 130 885 012 199TR-15 233 830 010 198 856 018 001.19C2 194.16M8 194.18M5 168.12M1 539.8M1 162AOB-015EF 164.12M1 111 837 014 137.16M1 147SRP-018 284.12M1S 294.12M4 245.14F1 237.10M1 237.18C2 198TR-13 171TF-S20 173TF-13 298 878K 012 294.12EC4 298 878K 016 168.14F1 237.18M3 277 379EF 023 237EX-26 257.25M1 168.18M1 237.20M1 544 845KR 021 164.14F1 165 858EF 010 001.9M1 237EX-41 126.12M2 032.15M1 199TR-25 001ABR-029C 033.14F1 197CR-21F 199TR-11C 194.16F5 170TF-S31 466 8833 031 156 835KR 010 199TR-25F 584.18EF1 160TC-11 197TR-21 162AOB-025F 198TR-13C 199TR-11F 107.14M2 137.18M1 194.16F7 194.18EF4 299 879K 012 237EX-21 170TF-SS31 466AOC-031F 160TC-11EF 245 8860 012 164.10EF4 001.29C2 107.8F1 039EX-12F 223 868 012 137.20F1 198 856 016 001.19C1 194.16M7 168.12F1 539.8F2 584.21M2 161AFN-010F 164.12F2 110SF-21 137.16F1 141SR-13F 299 879K 021 284.12C2 294.12M2 237EX-21F 245.13M1 233 830 016 198 8856 016 001.25M1 194.18C2 RSBTRM 168.18F2 465.16F1 544 845KR 016 164.14EC1 111SF-12 150.10M1 294.20M1 298FO-21F 294.16M4 237.21M1 257FO-32F 037.35M2 194ASM-016EF 197TR-62C 194.16C9 194.16M2 170TF-42 171TF-21 584.18M4 159.15F1 160TC-21F 068WR-13C 108JSF-010 137.14EC1 284.16M1 294.16EC3 255SOP-014C 237.14M2 194.22M1 199 850 014 172TF-14 194.14M1 168.16F1S 168.18EF2 169TF-41 552.21M1 DBGLK 164.18M1 168 845 012 297 877K 016 289 8878 010 294.14M3 294.18M2 257.25EC1 001.30EC1 019DI-42 194.20F1 196CR-11EF 194.13F1 194.16F1 168.21M1S 170TF-43F 584.16M2 160APC-014F 167-40D3 107.12M1 284.12M3 294.12M5 245.14M1 257.18M1 237.10M2 237.18EC3 171TF-S21 173TF-13C 168.14M1 168.18M1S 544 845KR 025 584.14M1 164.14F2 165 8858 010 156 835KR 016 284.135F1 288SO-20 294.14EC3 245.16EF1 257.18M2 237.12EC3 237.18M1 172 847 014 173TF-13EF 168.14M2 168.18M2 544 845KREF 018 584.16C3 164.14M1 166-85901010ML 156.10M1 297 877K 018 289 8878 016 294.18M3 257.25EF1 001.30M1 032.10M1 194.20F2 196CR-11F 199 850 018 194.14EC2 194.16F2 170TF-S22 584.18C5 160APC-016 167-50D3 107.13M1 137.18EC1 298 6878K 018 289SO-21 237.18M2 257.25F1 001.8M1 032.14M1 199TR-19C 194.20M2 197 855 025 199TR-11 194.16F3 170TF-S23 584.18EC2 160APC-016F 162AOB-025EF 167-80D3 107.14M1 137.18F1 284.14C2 288SO-S20 294.14EF5 245.16F1 257.21M1 001BR-41 237.12F3 194.18M5S 173TF-13F 168.14M3 168.18M3 544 845KREF 025 584.16EC2 159.25EF1 164.14M2 167 859 010 294.20F1 298FO-21EF 288 877 010 294.16M3 237.21F1 257FO-32 037.35M1 194ASM-016 194.16C5 194.16M1SS 168.16M1SS 170TF-31F 171TF-20 584.18M3 LABEC62 160TC-21EF 068WR-13 137.12M1 284.9M2 294.16F3 257 368 021 257.32M1 237.16C2 194.24C1 173TF-11 194.14M3 168.16F2 170TF-22 584 959KR 018 584.18F2 DBINK 164.9F1 168.11M1 129 884 012 298 878K 018 277 8379 018 237.21C1 238 6830RL 016 001ABR-S019C 201ASG-016C 197TR-21C 198TR-13EF 199TR-12 194.16M1 194.18EF5 168.16M2 170TF-SS31F 534.11EF1 164.10F2 107.8M2 137.20M1 277.23M1 284.16F2 294.14M5 255.18M1 237.14M1 199 850 012 172APB-021F 194.14F2 194.18M4 168.16F1 168.18C2 168.23M1 552.16M1 584.25M1 164.16M1 297 877K 012 284.14M2 289 6878 014 294.14M1 294.18F3 257.23M1 001BR-49 194.20EC2 194.12F2 194.16EF3 168.14M4 168.21F2 170TF-42F 584.16F3 160ACN-016C 167 859EF 010 284.14M1 289 6878 012 294.14F3 294.18EC3 245.16M1 257.23EF1 001BR-46 194.18M6 194.12EF1 168.14M3S 168.21EF2 ZR194.16M4 544 8845KR 018 584.16F2 159.25F1 167 859 018 299FO-11 284.12M1 294.12M3 245.14EF1 234EX-31 198 8856 018 001.29C1 173TF-12 194.18C5 168.12M2 168.18F3 544 845KR 018 164.14EF2 126.12M1 150EX-18F 277.23EF1 284.16EF1 243AFN-014EF 255.15M1 220AEZ-016C 277.18F1 237.14EC3 198TR-26F 238 830RL 014 172APB-021 194.18M2 247CD-57F 001BR-40 168.16EC5 215.16C1 168.16M6S 237.12M2 534.9M1 546 6847KR 018 198TR-26 584.25EF1 001.12M1 172APB-018EF 194.18F4 164.10M4 168.16M4 534.9EF1 164.16EF1 159.10F1 544 8845KR 025 164.10M1 164.16C1 141SR-12 157 836KR 012 299 879K 016 284.10M1 237EX-21EF 245.13F1 199TR-19 233 830 012 198 856EF 012 001.25EC1 194.18C1 NBRBEC50 465 8392 016 539.8M2 162AOB-015F 164.12M2 111SF-11 150.10F1 298FO-21 277 8379 021 238 6830RL 018 001ABR-S029C 201ASG-S016C 197TR-21EF 198TR-13F 001 801 009 172 847 016 194.16M1S 194.18F2 168.16M2S 534.11F1 164.10F3 108CD-58F 137.9M1 156.12M1

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NNI	Container, Specimen, Non-Sterile	Pathology	Class 1	864.3250	2015-10-12
EIX	Probe, Periodontic	Dental	Class 1	872.4565	2007-11-04
EKR	Plugger, Root Canal, Endodontic	Dental	Class 1	872.4565	2007-11-04
EHZ	Evacuator, Oral Cavity	Dental	Class 1	872.6640	2017-11-23
EMP	Marker, Periodontic	Dental	Class 1	872.4565	2012-05-18
EKC	Excavator, Dental, Operative	Dental	Class 1	872.4565	2007-11-04
EMO	Knife, Periodontic	Dental	Class 1	872.4565	2007-11-04
EMD	Hemostat, Surgical	Dental	Class 1	872.4565	2007-11-04
EEF	Clamp, Rubber Dam	Dental	Class 1	872.6300	2012-01-04
EKB	Explorer, Operative	Dental	Class 1	872.4565	2007-11-04
GFA	Blade, Saw, General & Plastic Surgery, Surgical	General, Plastic Surgery	Class 1	878.4820	2016-03-22
EGN	Scissors, Surgical Tissue, Dental	Dental	Class 1	872.4565	2007-11-04
EFK	Forceps, Articulation Paper	Dental	Class 1	872.4565	2012-01-04
EIG	Retractor, All Types	Dental	Class 1	872.4565	2007-11-04
HXL	Mallet	General, Plastic Surgery	Class 1	878.4800	2007-11-04
EJL	Bur, Dental	Dental	Class 1	872.3240	2009-04-09
EJY	Pliers, Operative	Dental	Class 1	872.4565	2007-11-04
EMK	Curette, Surgical, Dental	Dental	Class 1	872.4565	2007-11-04
EIY	Instrument, Filling, Plastic, Dental	Dental	Class 1	872.4565	2007-11-04
EHY	Tray, Impression, Preformed	Dental	Class 1	872.6880	2007-11-01
EKD	Instrument, Cutting, Operative	Dental	Class 1	872.4565	2014-11-12
EJG	Forceps, Rubber Dam Clamp	Dental	Class 1	872.6300	2014-03-17
EKG	Condenser, Amalgam And Foil, Operative	Dental	Class 1	872.4565	2009-04-09
EMG	Forceps, Tooth Extractor, Surgical	Dental	Class 1	872.4565	2007-11-04
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2017-11-23
EIL	Gauge, Depth, Instrument, Dental	Dental	Class 1	872.4565	2007-11-02
NDP	Accessories, Implant, Dental, Endosseous	Dental	Class 1	872.3980	2007-11-04
LCN	Scraper, Tongue	Dental	Class 1	872.6855	2007-11-04
EKH	Carver, Dental Amalgam, Operative	Dental	Class 1	872.4565	2007-11-04
EMN	Scaler, Periodontic	Dental	Class 1	872.4565	2007-11-04
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	Clinical Chemistry	Class 1	862.2050	2007-11-04
EKK	Spreader, Pulp Canal Filling Material, Endodontic	Dental	Class 1	872.4565	2007-11-04
EME	Punch, Biopsy, Surgical	Dental	Class 1	872.4565	2007-11-04
EJP	Articulators	Dental	Class 1	872.3150	2007-11-04
EBL	Pin, Retentive And Splinting, And Accessory Instruments	Dental	Class 1	872.3740	2007-11-04
DZA	Drill, Dental, Intraoral	Dental	Class 1	872.4130	2007-11-02
ECS	Pusher, Band, Orthodontic	Dental	Class 1	872.4565	2016-11-11
EIK	Carver, Wax, Dental	Dental	Class 1	872.4565	2007-11-01
EKA	File, Margin Finishing, Operative	Dental	Class 1	872.4565	2007-11-04
MXP	Bone Particle Collector	Ear, Nose, Throat	Class 1	874.4800	2007-11-04
EMJ	Elevator, Surgical, Dental	Dental	Class 1	872.4565	2007-11-04
EBR	Unit, Suction Operatory	Dental	Class 1	872.6640	2008-03-07
EIS	Remover, Crown	Dental	Class 1	872.4565	2007-11-04
DYJ	Retainer, Screw Expansion, Orthodontic	Dental	Class 1	872.5410	2015-12-02
EMS	Curette, Periodontic	Dental	Class 1	872.4565	2007-11-04
EAX	Mirror, Mouth	Dental	Class 1	872.4565	2007-11-01
EHM	Strip, Polishing Agent	Dental	Class 1	872.6010	2017-11-23
EKI	Carrier, Amalgam, Operative	Dental	Class 1	872.4565	2009-04-09
EIE	Dam, Rubber	Dental	Class 1	872.6300	2012-05-18
ECP	Instrument, Ligature Tucking, Orthodontic	Dental	Class 1	872.4565	2009-04-09
JEO	Measurer, Gingival Fluid	Dental	Class 1	872.1500	2012-04-25
EJI	Syringe, Cartridge	Dental	Class 2	872.6770	2008-03-09
EJZ	Knife, Margin Finishing, Operative	Dental	Class 1	872.4565	2007-11-04
EJB	Handle, Instrument, Dental	Dental	Class 1	872.4565	2007-11-04
GAC	Rasp, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2014-10-10
DZP	Instrument, Diamond, Dental	Dental	Class 1	872.4535	2014-05-26

Official Correspondent

In Joon Choi

US Agent Details

Nasser Sheikh Business: Brite Source USA Email: nasser@britesources.com Phone: (847) 3618637

Related Public Records

Same Entity

OSUNG MND CO., LTD.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K953012	Boston Surgical Products, Inc.	DISPOSABLE & REUSABLE SURGICAL CUTTING TOOLS	1995-07-12
K821275	Conphar, Inc.	MAYO SCISSOR STRAIGHT 5 1/2	1982-05-28
K851721	Artiberia	1200/1 TO 1240/15 VARIOUS TYPES OF DENTAL SCALERS	1985-07-02
K040797	Britesmile, Inc.	BRITESMILE MASKING CREAM	2004-04-02

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0013-2022	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	1	Scan Abutment SP, Cat. No. 30-70101 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0014-2022	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	1	Scan Abutment NP, Cat. No. 30-70102 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0015-2022	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	1	Scan Abutment MU, Cat. No. 30-70103 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0016-2022	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	1	Scan Abutment SU, Cat. No. 30-70104 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0017-2022	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	1	Scan Abutment PCA, Cat. No. 30-70105 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9616119. Last updated year: 2026. Please use registration number 9616119 when referencing this establishment in official correspondence.