SWEDEN & MARTINA S.P.A.

FDA Device Registration & Listing · Due Carrare Padova, IT · Registration 3001082453

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
3001082453
FEI Number
3001082453
Entity Name
SWEDEN & MARTINA S.P.A.
City/State/Country
Due Carrare Padova, IT
Establishment Address
Via Veneto, 10, Due Carrare Padova 35020, IT
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
SWEDEN & MARTINA S.p.A. (Owner Number: 10046682)
Owner / Operator Contact Address
Via Veneto, 10, Due Carrare, IT-PD 35020, IT
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
PMA Number
N/A

All Registered Proprietary Names

DENTAL HANDPIECE MILLABLE TITANIUM ABUTMENT MILLABLE TITANIUM SLEEVE SIMPLE TEMP. POST PEEK+TIT REP STRAIGHT PAD ABUTMENT, H4 MM PLAIN ABUTMENT H3 MM 25GR ANGLE PRE-MADE POST, REP. CAST. NON REP. POST WITH GOLD CASTABLE REP. POST WITH GOLD CASTABLE REP. POST WITH CRCO SIMPLE TEMP. POST TIT. NON REP 15GR ANGLE PRE-MADE POST, REP. MILLABLE REP. POST FOR STRAIGHT PAD ABUTMENT, H1.5 MM 17GR ANGLED PAD ABUT., H3 MM PRE-MADE REP. POST STRAIGHT 30GR ANGLED PAD ABUT., H3 MM PRE-ANGLED REP. MILLABLE POST STRAIGHT PAD ABUTMENT, H3 MM 30GR ANGLED PAD ABUT., H5 MM CAST. NON REP. POST WITH CRCO 17GR ANGLED PAD ABUT., H5 MM TRANSGINGIVAL HEALING CAP H7MM MILLABLE POST, REP. PLAIN ABUTMENT H4 MM TRANSGINGIVAL HEALING CAP H3MM TRANSGINGIVAL HEALING CAP H5MM PLAIN ABUTMENT H2 MM SIMPLE TEMP. POST TIT. REP. TRANSGINGIVAL HEALING CAP H2MM PRE-MADE REP. POST ANATOMICAL 17GR ANG. RED. PAD ABUT. 30GR ANG. RED. PAD ABUT. STRAIGHT RED. PAD ABUT. INSTRUMENT TRAY ECHOPLAN SURGICAL KIT "ONEBOX" REMOVAL SCREW KIT SURGICAL KIT ECHOPLAN PRO GLOBAL BONE EXPANDER KIT INSTRUMENTS TRAY FOR M.I.S.E. EVO KIT MOUNTER TRAY ORGANIZER SURGICAL KIT KIT D.B.E. SYSTEM OUTLINK2 SUPPLEMENTARY INSTR. SURGICAL KIT ECHOPLAN SURG. KIT FOR PREMIUM-SHELTA SURGICAL KIT "ONEBOX2" PROSTHETIC ACCESSORIES KIT PREMIUM SUPPLEMENTARY INSTR. STARTER PACK PRE-MADE REP. POST FOR PRAMA PRAMA WHITE IMPLANT ZIRTI PRE-MADE NON REP. POST FOR HEALING ABUTMENT PRAMA WHITE PRAMA RF WHITE IMPLANT ZIRTI STOP H.3,5 MM FOR DRILL CURVED HANDLE SUPPLEMENTARY KIT OUTLINK2 SUPPLEMENTARY KIT PREMIUM TRY-IN KIT FOR PREMIUM/KOHNO SURGICAL KIT FOR GLOBAL IMPLANT SYSTEM SURGICAL KIT FOR OUTLINK2 IMPLANT SYSTEM SURGICAL KIT FOR PRAMA SURGICAL KIT ONEBOX2 FOR OUTLINK2 IMPLANT SYSTEM BREAK UP DRILL D. 30 MM TRANSFER ECHO FOR PRE-KOH TG SURGICAL KIT FOR SHELTA IMPLANT SYSTEM M.I.S.E. EVO KIT REPLY FOR SHELTA IMPLANT D. 50 MM, L. 10 MM BONE EXPANDER FOR D.B.E SURGICAL KIT ONEBOX FOR PREMIUM IMPLANT SYSTEM PROSTHETIC ACCESSORIES KIT REPLY FOR SHELTA IMPLANT D. 3.80 MM, L. 13 MM INTERMEDIATE DRILL D. 2.50 MM STOP H.5 MM FOR DRILL REPLY FOR SHELTA IMPLANT D. 4.25 MM, L. 8.5 MM REPLY FOR GLOBAL IMPLANT D. 5.50 MM, L. 11.5 MM SHORTY DRILLING KIT REPLY FOR SHELTA IMPLANT D. 3.80 MM, L. 15 MM REPLY FOR SHELTA IMPLANT D. 3.80 MM, L. 10 MM REPLY FOR GLOBAL IMPLANT D. 5.50 MM, L. 13 MM REPLY FOR GLOBAL IMPLANT D. 5.50 MM, L. 8.5 MM ROUNDED DRILL D. 40 MM DOUBLE MOUNTER STOP KEY FOR MILLABLE TITANIUM ABUTMENT KIT D.B.E. SYSTEM INITIAL DRILL D. 20 MM REMOVAL SCREW KIT FOR OUTLINK2 RIGHT ANGLE RETENTIVE DRIVER LONG DRIVER FOR GLOBAL IMPL. SURGICAL KIT FOR PREMIUM IMPLANT SYSTEM ABUTMENT ECHO KOHNO PREMIUM SURGICAL KIT ECHOPLAN OUTLINK2 SURGICAL KIT ECHOPLAN SCREW KIT TRANSFER 4.25 PR/SH REPLY FOR GLOBAL IMPLANT D. 4.30 MM, L. 11.5 MM REPLY FOR GLOBAL IMPLANT D. 4.80 MM, L. 11.5 MM REMOVAL SCREW KIT FOR GLOBAL SURGICAL KIT FOR PRE/KOH IMPLANT SYSTEM REPLIES FOR SHELTA IMPLANTS REPLY FOR SHELTA IMPLANT D. 50 MM, L. 11.5 MM PLUGGER AND DEPTH GAUGE "SURGICAL KIT ""ONEBOX2""" ABUTMENT ECHO PREMIUM "SURGICAL KIT ""ONEBOX""" HOLDER FOR PREMIUM SHORT DRILL DIAM. 3,00 MM REPLY FOR GLOBAL IMPLANT D. 5.50 MM, L. 10 MM REPLY FOR GLOBAL IMPLANT D. 4.30 MM, L. 15 MM REPLY FOR GLOBAL IMPLANT D. 4.30 MM, L. 8.5 MM STOP H.10 MM FOR DRILL HAND BONE TAP FOR GLOBAL INTERMEDIATE DRILL GLOBAL REPLY FOR SHELTA IMPLANT LONG DRILL DIAM. 4,00 MM REPLY FOR SHELTA IMPLANT D. 4.25 MM, L. 10 MM REPLY FOR GLOBAL IMPLANT D. 4.30 MM, L. 10 MM TRANSFER 3.80 PR/SH OUTLINK2 SUPPLEMENTARY INSTR. TITANIUM SUPPORT MOUNTER OUTLINK2 D. 5,00 MM SHORT DRILL DIAM. 3,80 MM REPLY FOR SHELTA IMPLANT D. 50 MM, L. 15 MM STOP H.6 MM FOR DRILL SHORT DRILL DIAM. 2,80 MM LONG DRILL DIAM. 4,25 MM COUNTERSINK FOR OUTLINK2 TRANSFER P.A.D. REPLY FOR GLOBAL IMPLANT D. 4.80 MM, L. 10 MM GLOBAL BONE PROFILER LONG DRILL DIAM. 3,00 MM SHORT STOP H. 10, D. 4,15 MM REPLY FOR SHELTA IMPLANT D. 4.25 MM, L. 13 MM HAND DRIVER FOR ABUTMENT SHORT DRILL DIAM. 2,00 MM MOUNTER OUTLINK2 D. 3,30 MM SHORT STOP H. 7, D. 5,50 MM REPLY FOR GLOBAL IMPLANT D. 4.30 MM, L. 13 MM REPLY FOR GLOBAL IMPLANT D. 3.80 MM, L. 11.5 MM SHORT STOP H. 11,5, D. 4,15 MM SHORT STOP H. 11,5, D. 5,50 MM SURGICAL HAND SCREWDRIVER FOR REPLY FOR GLOBAL IMPLANT D. 4.80 MM, L. 13 MM STOP H.9 MM FOR DRILL SURGICAL KIT ECHOPLAN BONE TAP PREMIUM D. 4,25 MM SHORT STOP H. 7, D. 4,15 MM MOUNTER STOP KEY FOR TRANSFER 3.30 PR/SH REPLY FOR GLOBAL IMPLANT D. 3.80 MM, L. 15 MM REPLY FOR SHELTA IMPLANT D. 3.80 MM, L. 11.5 MM ROUND TIP OSTEOTOME FOR GLOBAL ABUTMENT ECHO OUTLINK2 LONG DIGITAL RETENTIVE DRIVER GLOBAL BONE EXPANDER KIT REPLY FOR SHELTA IMPLANT D. 50 MM, L. 13 MM REPLY FOR GLOBAL IMPLANT D. 4.80 MM, L. 8.5 MM ROUND TIP OSTEOTOME FOR SHELTA SHORT DRILL DIAM. 3,30 MM LONG DRILL DIAM. 2,50 MM LONG STOP H. 15, D. 5,50 MM RETENT.SHORT R.A. EASY INSERT NON RETENTIVE DIGITAL DRIVER REPLY FOR GLOBAL IMPLANT D. 3.80 MM, L. 13 MM TRANSFER 50 PR/SH O-RING KIT FOR INSTRUMENTS TRANSFER ECHO FOR GLOBAL REPLY FOR SHELTA IMPLANT D. 50 MM, L. 8.5 MM ROUND TIP OSTEOTOME D.90 MILLABLE CRCO ABUTMENT DOUBLE TIP PLUGGER ROUNDED DRILL D. 30 MM SURGICAL KIT "ONEBOX2" HANDLE FOR D.B.E.SYSTEM STOP H.1 MM FOR DRILL REPLY FOR GLOBAL IMPLANT FINAL CYLINDRICAL DRILL RIGHT ANGLE BONE TAP TRANSFER P.A.D. FOR CAD-CAM SHORT SCREW DRIVER FOR LOCATOR STOP FOR CONICAL DRILL RIGHT ANGLE DRIVER FOR GLOBAL- INTERMEDIATE DRILL CONCAVE TIP OSTEOTOME D.20 RETENT.EASY INSERT HAND DRIVER ABUTMENT ECHO GLOBAL STOP H.3 MM FOR DRILL PREMIUM SUPPLEMENTARY INSTR. REPLY FOR GLOBAL IMPLANT D. 4.80 MM, L. 15 MM STOP H.11 MM FOR DRILL STOP UNLOCKING HANDLE LONG SURGIC. HAND SCREWDRIVER LONG STOP H. 15, D. 4,15 MM LONG DRILL DIAM. 3,40 MM REPLY FOR GLOBAL IMPLANT D. 3.80 MM, L. 10 MM STOP H.4 MM FOR DRILL REPLY FOR SHELTA IMPLANT D. 4.25 MM, L. 15 MM REPLY FOR GLOBAL IMPLANT D. 5.50 MM, L. 15 MM TRANSFER ECHO FOR OUTLINK2 ROUNDED DRILL D. 3.40 MM STOP H.8 MM FOR DRILL SHORT DIGITAL RETENT. DRIVER SUPPLEMENTARY DRILLS SET HEXAGONAL SCREWDRIVER FOR PILOT DRILL GLOBAL SURGICAL KIT "ONEBOX" REPLY FOR SHELTA IMPLANT D. 4.25 MM, L. 11.5 MM STOP H.7 MM FOR DRILL TRANSFER ECHO FOR PREMIUM REPLY FOR GLOBAL IMPLANT D. 3.80 MM, L. 8.5 MM STOP H.2 MM FOR DRILL CHAMFERED DRILL D. 30 MM STOP H.12 MM FOR DRILL STOP H.13 MM FOR DRILL STOP UNLOCKING HOLDER MOUNTER OUTLINK2 D. 4,10 MM LONG STOP H. 13, D. 4,15 MM MOUNTER WITH SCREW FOR PRE/KOH SHORT SURGIC. HAND SCREWDRIVER RETENT.LONG R.A. EASY INSERT PARALLELISM PIN WITH DEPTH CARRIER FOR ANGLED ABUTMENT RIGHT ANGLE CONNECTOR X-RAY TEMPLATES LONG DRILL DIAM. 2,80 MM TEFLON CAP BALL ATTACHMENTS HOLDER FOR PREMIUM SP SHORT DRILL DIAM. 3,40 MM SURGICAL SLEEVE DIAM. 5,50 MM RIGHT ANGLE SCREWDRIVER FOR LONG DRILL DIAM. 3,20 MM FINAL CONICAL DRILL GLOBAL SHORT DRILL DIAM. 2,90 MM INITIAL DRILL BUILT-IN STOP COUNTER ANGLE FOR SURGERY 20:1 EXTRA LONG PROSTHETIC HAND SILICONE SUPPORT FOR SURGICAL CONCAVE TIP OSTEOTOME D.2.40 LONG DRILL DIAM. 2,90 MM UNIVERSAL INITIAL MUCOTOME SHORT DRILL DIAM. 4,00 MM REPLY FOR SHELTA IMPLANT D. 3.80 MM, L. 8.5 MM REMOVAL SCREW KIT FOR PRE/KOH SHORT STOP H. 10, D. 5,50 MM SHORT STOP H. 8,5, D. 4,15 MM STOP FOR CYLINDRICAL DRILL DEPTH GAUGE HOLE IMPLANTS MOUNTER STOP KEY NON RETENT. LONG HAND DRIVER PRECISION DRILL XS SURGICAL HAND SCREWDRIVER ABUTMENT ECHO PREMIUM-KOHNO LONG DRILL DIAM. 2,00 MM INSTRUMENT TRAY ECHOPLAN SILICONE SUPPORT FOR SCREWKIT HAND BONE TAP FOR SHELTA HAND BONE TAP FOR PRE/KOH SHORT HAND BONE TAP EXTENSION FOR HAND SCREWDRIVER COUNTERSINK FOR PREMIUM SP NON RETENT. SHORT HAND DRIVER BONE TAP PREMIUM SP D.3,80 MM CASTABLE CAP FOR PREMADE ABUT SURGICAL SLEEVE DIAM. 4,15 MM PRE-MADE REP. ABUT STRAIGHT SURG. KIT FOR PREMIUM-SHELTA TEFLON CAP CONTAINER FOR BALL LONG DRILL DIAM. 3,80 MM BONE TAP PRE/OUT D. 3,30 MM SHORT STOP H. 8,5, D. 5,50 MM BONE TAP PREMIUM D. 5,00 MM STOP FOR SHORT DRILL SURGICAL KIT CONCAVE TIP OSTEOTOME D.1.60 TRY-IN KIT FOR PREMIUM LONG STOP H. 13, D. 5,50 MM MOUNTER HAND DRIVER LONG DRILL DIAM. 3,30 MM PARALLEL PIN HAND BONE TAP FOR KOHNO HAND KNOB FOR DRIVERS, BONE SHORT DRILL DIAM. 4,25 MM SHORT DRILL DIAM. 2,50 MM BONE TAP FOR OUTLINK2 UNIVERSAL BONE PROFILER SHORT DRILL DIAM. 3,20 MM BONE TAP PREMIUM D. 3,80 MM FINAL CONICAL DRILL SHELTA HAND DRIVER FOR TITANIUM CAP INSTRUMENTS TRAY FOR BRUSH LONG PROSTHETIC HAND CYLINDRICAL PILOT DRILL HAND BONE TAP FOR PREMIUM TORQUE CONTROLLED RATCHET KIT TORQUE WRENCH WITH LEVER PRE/KOH BONE PROFILER PRE-MADE REP. ABUT ANATOMICAL EXTRA SHORT SURGICAL HAND SHORT PROSTHETIC HAND COUNTERSINK DRILL D.4.10 MM PREMIUM BONE PROFILER HAND DRIVER FOR R.A. INSTRUM. LONG SCREW DRIVER FOR LOCATOR EXTENSION FOR SURGICAL DRILLS ROUND TIP OSTEOTOME D.20 HAND SCREWDRIVER FOR BALL FLAT TIP OSTEOTOME FOR SHELTA SHORT DRILL DIAM. 3,60 MM LONG DRILL DIAM. 3,60 MM CONICAL DRILL PEEK CAP FOR PREMADE POST SURGICAL SLEEVE WITH HEX.DIAM. CSR STOP FOR CYLINDRICAL DRILL SCREW ZIRCONIUM ABUTMENT PILOT DRILL PERI-SET , KIT FOR SURGICAL MILLABLE TITANIUM SLEEVE ANALOGUE FOR ABUTMENT BOX FOR PRE-MADE ABUTMENT HEALING CAP FOR PRE-MADE ABUT TEMPORARY ABUTMENT TEMP. CAP FOR PRE-MADE ABUT SCANBODY iNTRAORAL RIGHT ANGLE SCREWDRIVER PULL-UP TRANSFER BONE PROFILER SLEEVE COUNTERSINK DRILL PINS DRILL TAPERED FINAL DRILL SPARE CAST. SLEEVE FOR GOLD INTRAORAL SCANBODY ANCHOR PIN SUPPLEMENTARY INSTRUM. SET TAPERED FINAL DRILL UNDERP. CASTABLE POST, REP., CR-CO ABUTMENT SCREW M 2 TITANIUM SLEEVE FINAL CONICAL DRILL SYRA SHORT CLOSED TRAY TRANSFER STOP FOR CONICAL SYRA SHORT TI POST ANATOMICAL CRCO POST ANATOMICAL CASTABLE POST,NON REP., CR-CO ANALOGUE FOR PRAMA IMPLANT TAPERED BONE TAP CYLINDRICAL FINAL DRILL MOUNTER PRAMA, FOR SLEEVE CASTABLE POST,NON REP., GOLD CRCO POST STRAIGHT EXTRALONG PROSTHETIC HAND POST SCREW FOR PRAMA IMPLANT TI POST STRAIGHT SURGICAL KIT ECHOPLAN PRO SURGICAL SLEEVE FOR ANCHOR PIN ABUTMENT SCREW M1.8 X-RAY TEMPLATES FOR PRAMA AND PICK-UP TRANSFER FOR PRAMA MOUNTER TRAY ORGANIZER NECK POSITION PIN ABUTMENT TIT. D.12 M-TWO INSTRUMENT EASY MOUNTER GUIDED SURGERY PIVOT HANDLE FOR MANUAL INSERTION CLUTCH DRILL SPIRAL DRILL PARALLELOMETER SCREW INSERTION INSTRUMENT DEPTH GAUGE MUCOTOME DRILL STOP H.1,5 MM FOR DRILL PEEK OSTEOTOME TIP HANDLE STOP H.4,5 MM FOR DRILL STOP H.2,5 MM FOR DRILL EXTRACTOR SCREW PIN DIGITAL ANALOGUE THREAD FORMER M.1.8 THREAD FORMER M.2 STOP H.5,5 MM FOR DRILL MOUNTER SCREW MASTER SLEEVE MOUNTER CYLINDRICAL DRILL FINAL CONICAL DRILL BRIDGE 12 ELEMENTS FULL BODY POST PREPARATION DRILLS KIT FOR TEMPORARY BRIDGES FOR B.O.P.T. PREPARATION DRILLS KIT FOR B.O.P.T. DIAMOND BUR SCREW KIT SHORTY DRILLING KIT FEMALE PART T COMPLETE L47.5 ABUTMENT PLAIN SCREWS M2 LOCATOR LIGHT RETENTION EXTEND COMPLETE PACKAGING FOR LOCATOR ABUTMENT PRE/KOH TG HAND BONE TAP FOR PRE/KOH ADD-ON KIT ANALOGUE FOR IMPLANT TRANSFER SCREW M1.8 H20 MM SOLID ONE-PIECE ABUTMENT, H7MM SFI-BAR IMPLANT ADAPTER SILICONE SUPPORT FOR SURGICAL RETENT.EASY INSERT HAND DRIVER ABUTMENT SCREW M2 TITANIUM SLEEVE FOR PAD ABUT. LOCATOR EXTRA LIGHT RETENTION POST BOPT TECHNIQUE, INSERT POSITIONER ROUND TIP OSTEOTOME D.20 CASTABLE REP. POST WITH CRCO NON REP. CAST.SLEEVE FOR ABUT. SHELTA IMPLANT ZIRTI WIDE POLYAMIDE CAP BALL ATTACHMENTS PULL-UP TRANSFER FOR PRE-KOH OPEN TRAY TRANSF.FOR PRE-KOHTG GAUGE AID TUBE BAR GAUGE TRANSGINGIVAL HEALING CAP BOPT RETENTION INSERT G RED LOCATOR ABUTMENT PRE/KOH 4,25 SCREW M1.8 FOR RIP.ABUTMENT HEALING PEEK CAP. WITH NARROW SURGICAL COVER SCREW PREMIUM SCREW FOR ABUTMENT TRANSFER INTERMEDIATE DRILL 25GR ANGLE PRE-MADE POST, REP. ROUND TIP OSTEOTOME D.90 HAND DRIVER FOR R.A. INSTRUM. ACTIVATOR SET FOR FEMALE PARTS SHORT SCREW DRIVER FOR LOCATOR STRAIGHT PAD ABUTMENT, H1.5 MM HEALING CAP FOR ABUTMENT LOCATOR MALE PROCESSING PACK. TRANSFER JIG L26 FOR HAND BONE TAP FOR SHELTA STEEL CAP (2 PCS) NON RETENT. SHORT HAND DRIVER HEALING CAP FOR PLAIN ABUTMENT CAST. NON REP. POST WITH GOLD X-RAY TEMPLATES TWEEZERS LOCATOR MALE REMOVAL (TIP END) PREMIUM STRAIGHT IMPLANT ZIRTI PILOT DRILL FEMALE PART HOUSING T L47.5 OPEN TRAY TRANSFER FOR ABUT. CLOSED TRAY TRANSF.FOR PREMIUM PEEK CAST.SLEEVE FOR PAD ABUT. SIMPLE TEMP. POST TIT. REP. SPARE PLASTIC RING 30GR ANGLED PAD ABUT., H5 MM P.A.D. ABUTMENT SCREWS M2 LARGE BALL JOINT S POST SCREW M2 STOP FOR CONICAL DRILL HAND SCREWDRIVER FOR BALL LOCATOR FEMALE ANALOG (D.4 MM) OPEN TRAY TRANSF.FOR PAD ABUT. TRANSFER SCREW M2 H10 MM REP. STRAIGHT ABUTMENT, H1 MM TRANSGINGIVAL HEALING CAP H1.3 HEALING CAP FOR PREMIUM SP IMPLANT ZIRTI O-RING KIT FOR INSTRUMENTS 2-IMPLANT KIT TRANSGINGIVAL HEALING CAP H7MM TORQUE CONTROLLED RATCHET KIT CASTABLE CENTERING DEVICE FOR TRANSFER SCREW M2 FOR LOCATOR REPLACEMENT MALE, PRE-MADE REP. POST STRAIGHT CONCAVE TIP OSTEOTOME D.2.40 LOCATOR ABUTMENT PRE/KOH 3,30 POST SCREW M 2 P.A.D. ABUTMENT SCREW M1.8 LOCATOR WHITE BLOCK-OUT SPACER TRANSFER SCREW M2 H15 MM IMPLANT PLANNER PMMA CAST.SLEEVE FOR PAD ABUT. SIMPLE TEMP.POST PEEK EXTERNAL MOUNTER WITH SCREW FOR PRE/KOH STOP FOR CYLINDRICAL DRILL REP. STRAIGHT ABUTMENT, H2 MM OPEN TRAY TRANSF.FOR NON RIP. ANALOGUE FOR PLAIN ABUTMENT TRANSGINGIVAL HEALING CAP H4,3 SHELTA IMPLANT ZIRTI WIDE LOCATOR IMPRESSION COPING SMALL BALL JOINT S CASTABLE REP. POST WITH GOLD GOLD PINS U PROFILE FOR ROUND SPARE CASTABLE SLEEVE FOR GOLD MILLABLE POST, REP. ANALOGUE FOR BALL ATTACHMENT SOLID ONE-PIECE ABUTMENT PLAIN ABUTMENT H2 MM PLAIN ABUTMENT H4 MM ABUTMENT SCREW M1.8 POST SCREW M1.4 POST SCREW M 1.8 FINAL CILINDRICAL DRILL CARRIER FOR ANGLED ABUTMENT TRANSFER SCREW M14 FOR P.A.D. NON REP. ABUTMENT FOR SURGICAL COVER SCREW PRE/KOH CASTABLE BAR, OVOIDAL PROFILE CYLINDRICAL PILOT DRILL LOCATOR PARALLEL POST (4 PCS) SIMPLE TEMP.POST TIT. EXTERNAL OPEN TRAY TRANSFER FOR PRE-KOH 15GR ANGLE PRE-MADE POST, REP. HAND DRIVER FOR ABUTMENT PARALLEL PIN TRANSGINGIVAL HEALING CAP H2,8 OPEN TRAY TRANSFER SCREW M1.8 STOP FOR SHORT DRILL P.A.D. ABUTMENT SCREWS M1.8 POST SCREWS M 1.8 THOMAS SPANNER KEY FOR SCREW RED O-RING BALL ATTACHMENTS SCREWDRIVER FOR IMPLANTAT RIGHT ANGLE SCREWDRIVER FOR 17GR ANGLED PAD ABUT., H3 MM EXTRA SHORT SURGICAL HAND STEEL CAP CONTAINER FOR BALL LOCATOR ABUTMENT PRE/KOH 3,80 FINAL CONICAL DRILL SHELTA EXTENSION FOR HAND SCREWDRIVER RIGHT ANGLE CONNECTOR IMPRESSION TAKING CAP FOR HEALING CAP FOR PRE-MADE POSTS FEMALE PART ASYMMETRICAL 3 L30 CONCAVE TIP OSTEOTOME D.20 PRE-MADE REP. POST ANATOMICAL RETENTION INSERT G YELLOW DEPTH GAUGE HOLE IMPLANTS LOCATORE CORE TOOL FOR LOCATOR GOLDEN BOX FOR O-RINGS HEX KEY FOR FIXATION SCREW TRANSGINGIVAL HEALING CAP H2.8 HAND BONE TAP FOR PREMIUM TITANIUM SLEEVE FOR NON REP. ANALOGUE FOR PRE-KOH TG ABUT. DESACTIVATOR MACRO FOR FEMALE GOLD CAP D 2.20 MM CASTABLE CAP FOR PREMADE POSTS RITENTION JACKET (4PS) FOR THE SIMPLE TEMP. POST TIT. NON REP REP. CASTABLE SLEEVE FOR ABUT. STRAIGHT PAD ABUTMENT, H3 MM BALL ATTACHMENT IMPL. PRE/KOH SIMPLE TEMP.POST TIT. INTERNAL MILLABLE REP. POST FOR MILLABLE POST, REP., INTERNAL TRANSGINGIVAL HEALING CAP H3MM TRANSFER SCREW M1.8 H10 MM SPARE CAST. SLEEVE FOR GOLD OPEN TRAY TRANSFER FOR PREMIUM CASTABLE BAR ROUND PROFILE EXTRA LONG PROSTHETIC HAND ANALOGUE FOR ABUTMENT PLAIN ABUTMENT H3 MM SPARE RETENTION SPRING TIT.CAP P.A.D. ABUTMENT SCREW M2 SPARE SOFT RETENTION SPRING RETENTIVE TOP FOR PRE-ANGLED REP. MILLABLE POST CAST. SLEEVE FOR 20GR ANGLED RETENT.LONG R.A. EASY INSERT PULL-UP TRANSFER FOR PREMIUM REPOSITIONABLE ABUTMENT FOR SIMPLE TEMP. POST PEEK+TIT REP ANALOGUE FOR PAD ABUTMENT CAST.REP. POST WITH TITANIUM STRAIGHT PAD ABUTMENT, H4 MM HAND KNOB FOR DRIVERS, BONE PREMIUM DISC NO 1 REP. TITANIUM SLEEVE FOR ABUT. LONG SCREW DRIVER FOR LOCATOR 30GR ANGLED PAD ABUT., H3 MM MILLABLE POST, REP., EXTERNAL TITANIUM CAP FOR STANDARD BALL HAND BONE TAP FOR KOHNO SPARE CAST. SLEEVE FOR SHELTA IMPLANT ZIRTI REGULAR POST SCREWS M1.8 POM CAP FOR IMPRESSION TAKING LONG PROSTHETIC HAND ABUTMENT PLAIN SCREW M2 TRANSGINGIVAL HEALING CAP H1,3 SHORT PROSTHETIC HAND 20GR ANGLE PRE-MADE POST, REP. LOCATOR ABUTMENT DRIVER (GOLD ANGLE MEASUREMENT GUIDE NON REP. TIT.SLEEVE FOR ABUT. 4-IMPLANT KIT SURGICAL COVER SCREW 17GR ANGLED PAD ABUT., H5 MM TRANSGINGIVAL HEALING CAP H2MM ANALOGUE FOR IMPLANT D.3,80 MM PRE/KOH BONE PROFILER CONCAVE TIP OSTEOTOME D.1.60 FINAL CYLINDRICAL DRILL RETENTION INSERT G GREEN ANALOGUE,SOLID ONE-PIECE ABUT. MOUNTER STOP KEY POST SCREWS M1.4 SILICONE SUPPORT FOR SCREWKIT TIT. SLEEVE FOR PAD ABUTMENT EXTENSION FOR SURGICAL DRILLS POST SCREWS M2 FIXATION SCREW S T-CONNECT FOR SINGLE PREMIUM IMPLANT ZIRTI TG LOCATOR LIGHT RETENTION MALE, RIGHT ANGLE BONE TAP PROSTHETIC SCREW M1.4 FOR INSTRUMENT SET LONG SURGIC. HAND SCREWDRIVER T CONNECT FOR IMPLANT TRANSGINGIVAL HEALING CAP H5MM OPEN TRAY TRANSF.FOR RIP.ABUT. CAST. NON REP. POST WITH CRCO NON RETENT. LONG HAND DRIVER WHITE O-RING BALL ATTACHMENTS LOCATOR EXTEND.RANGE RETENTION SHORT SURGIC. HAND SCREWDRIVER CAST. NON REP. POST WITH CR-CO HALF SHELL BALL S OPEN TRAY TRANSFER RUBBER O-RING 3,50x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DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2019-07-15
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2019-07-15
NDP Accessories, Implant, Dental, Endosseous Dental Class 1 872.3980 2014-07-18
NSM Restoration, Resin Unknown Class N N/A 2024-03-25
DZA Drill, Dental, Intraoral Dental Class 1 872.4130 2014-04-28
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2021-08-25
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2015-02-04
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2015-02-04
NSN Restoration, Resin, Crown And Bridge Unknown Class N N/A 2024-03-25
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2018-02-12
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2016-12-06
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2016-12-06

Official Correspondent

No official correspondent registered.

US Agent Details

Silvia Tamarri Business: THEMA CORP Email: usreg@complifegroup.com Phone: (215) 8459459

Related Public Records

Same Entity

SWEDEN & MARTINA S.p.A.
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
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 3001082453. Last updated year: 2026. Please use registration number 3001082453 when referencing this establishment in official correspondence.
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