Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9614404

FEI Number

3002807318

Entity Name

Straumann Villeret SA

City/State/Country

VILLERET Bern, CH

Establishment Address

LES CHAMPS DU CLOS 2, VILLERET Bern CH-2613, CH

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

INSTITUT STRAUMANN AG (Owner Number: 9005052)

Owner / Operator Contact Address

PETER MERIAN-WEG 12, BASEL, CH-NOTA CH-4002, CH

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K071919

PMA Number

N/A

All Registered Proprietary Names

Straumann Dental Implant System Straumann Dental Implant System Screw Retained Abutments Straumann Dental Implant System RC Temporary Abutment Straumann CARES Abutments Straumann Dental Implant System Straumann Dental Implant System Straumann PURE Ceramic Implants Straumann Variobase for Crown AS Straumann Dental Implant System STRAUMANN DENTAL IMPLANT SYSTEM synOcta abutment Pre-milled Abutment Blank for CARES® NC GOLD ABUTMENT FOR CROWNS Straumann® BLX Temporary Abutment, VITA CAD-Temp, PMMA Straumann Dental Implant System NC Healing Abutment TLX Screw-Retained Abutments WN Gold Abutment, for Bridge RN Gold Abutment, for Bridge Neodent Titanium Block for Medentika Holder Straumann Pre-Milled Abutment Blank for Medentika Holder Straumann InLab Validated Workflow NNC Variobase Abutment, with screw, D 55mm, H 4mm, TAN NC Variobase Abutment with screw, D 3.8mm, H 3.5mm, TAN RN Variobase Abutment, with screw, D 55mm, H 4mm, TAN RC Variobase Abutment, with screw, D 4.5mm, 3.5mm, TAN WN Variobase Abutment, with screw, D 7mm, H 4.5mm, TAN Straumann Dental Implant System Straumann Dental Implant System Straumann Dental Implant System Straumann PUREloc Abutments SRBB Bone Level Straumann Dental Implant System Straumann Dental Implant System 033.561S Standard Plus TL, RN, Ø4.1mm, SLActive 8mm, TiZr 033.563S Standard Plus TL, RN, Ø4.1mm, SLActive 12mm, TiZr 033.624S Tapered Effect, TL, WN, Ø4.1mm, SLActive 14mm, TiZr 033.614S Standard Plus TL, WN Ø4.8mm, SLActive 14mm, TiZr 033.534S Standard TL, RN, Ø4.1mm, SLActive 14mm, TiZr 033.602S Standard TL, WN Ø4.8mm, SLActive 10mm, TiZr 033.582S Standard TL, RN, Ø4.8mm, SLActive 10mm, TiZr 033.592S Standard Plus TL, RN, Ø4.8mm, SLActive 10mm, TiZr 033.532S Standard TL, RN, Ø4.1mm, SLActive 10mm, TiZr 033.560S Standard Plus TL, RN, Ø4.1mm, SLActive 6mm, TiZr 033.535S Standard TL, RN, Ø4.1mm, SLActive 16mm, TiZr 033.612S Standard Plus TL, WN Ø4.8mm, SLActive 10mm, TiZr 033.571S Tapered Effect, TL, RN, Ø4.1mm, SLActive 8mm, TiZr 033.622S Tapered Effect, TL, WN, Ø4.1mm, SLActive 10mm, TiZr 033.531S Standard TL, RN, Ø4.1mm, SLActive 8mm, TiZr 033.533S Standard TL, RN, Ø4.1mm, SLActive 12mm, TiZr 033.593S Standard Plus TL, RN, Ø4.8mm, SLActive 12mm, TiZr 033.564S Standard Plus TL, RN, Ø4.1mm, SLActive 14mm, TiZr 033.623S Tapered Effect, TL, WN, Ø4.1mm, SLActive 12mm, TiZr 033.530S Standard TL, RN, Ø4.1mm, SLActive 6mm, TiZr 033.594S Standard Plus TL, RN, Ø4.8mm, SLActive 14mm, TiZr 033.611S Standard Plus TL, WN Ø4.8mm, SLActive 8mm, TiZr 033.573S Tapered Effect, TL, RN, Ø4.1mm, SLActive 12mm, TiZr 033.590S Standard Plus TL, RN, Ø4.8mm, SLActive 6mm, TiZr 033.583S Standard TL, RN, Ø4.8mm, SLActive 12mm, TiZr 033.601S Standard TL, WN Ø4.8mm, SLActive 8mm, TiZr 033.572S Tapered Effect, TL, RN, Ø4.1mm, SLActive 10mm, TiZr 033.610S Standard Plus TL, WN Ø4.8mm, SLActive 6mm, TiZr 033.584S Standard TL, RN, Ø4.8mm, SLActive 14mm, TiZr 033.562S Standard Plus TL, RN, Ø4.1mm, SLActive 10mm, TiZr 033.580S Standard TL, RN, Ø4.8mm, SLActive 6mm, TiZr 033.613S Standard Plus TL, WN Ø4.8mm, SLActive 12mm, TiZr 033.581S Standard TL, RN, Ø4.8mm, SLActive 8mm, TiZr 033.603S Standard TL, WN Ø4.8mm, SLActive 12mm, TiZr 033.574S Tapered Effect, TL, Ø4.1mm, SLActive 14mm, TiZr 033.600S Standard TL, WN Ø4.8mm, SLActive 6mm, TiZr 033.591S Standard Plus TL, RN, Ø4.8mm, SLActive 8mm, TiZr RC abutment, 17, D 4.6 mm, GH 5.5 mm, TAN, Type A NC abutment, 30, D 4.6 mm, GH 5.5 mm, TAN, Type B NC abutment, 17, D 4.6 mm, GH 5.5 mm, TAN, Type B NC abutment, 17, D 4.6 mm, GH 5.5 mm, TAN, Type A RC abutment, 30, D 4.6 mm, GH 5.5 mm, TAN, Type A RC abutment, 17, D 4.6 mm, GH 5.5 mm, TAN, Type B Screw-Retained Abutments NC abutment, 30, D 4.6 mm, GH 5.5 mm, TAN, Type A RC abutment, 30, D 4.6 mm, GH 5.5 mm, TAN, Type B NC Straumann® Anatomic IPS e.max® Abutment straight, GH 2mm, MO 0, ZrO2 NC Straumann® Anatomic IPS e.max® Abutment angled 15, GH 2mm, MO 0, ZrO2 NC Straumann® Anatomic IPS e.max® Abutment straight, GH 3.5mm, MO 0, ZrO2 NC Straumann® Anatomic IPS e.max® Abutment straight, GH 2mm, MO 1, ZrO2 NC Straumann® Anatomic IPS e.max® Abutment angled 15, GH 2mm, MO 1, ZrO2 NC Straumann® Anatomic IPS e.max® Abutment straight, GH 3.5mm, MO 1, ZrO2 NC Straumann® Anatomic IPS e.max® Abutment angled 15, GH 3.5mm, MO 0, ZrO2 NC Straumann® Anatomic IPS e.max® Abutment angled 15, GH 3.5mm, MO 1, ZrO2 Straumann Dental Implant System Straumann Dental Implant System Straumann BLX Gold Abutment STRAUMANN DENTAL IMPLANT SYSTEM STRAUMANN DENTAL IMPLANT SYSTEM Straumann Dental Implant System RB/WB Screw-retained abutment, angled 17° & 30°, 4.6mm BLC Implant 3.75mm RB, SLA® 18mm, Roxolid® BLC Implant 3.75mm RB, SLActive® 18mm, Roxolid® NC Screw-retained abutment, TAN, angled 17, D 4.6mm, GH 2.5mm, Type A NC Screw-retained abutment, TAN, angled 17, D 4.6mm, GH 4mm, Type A NC Screw-retained abutment, TAN, angled 30, D 4.6mm, GH 2.5mm, Type A NC Screw-retained abutment, TAN, angled 30, D 4.6mm, GH 2.5mm, Type B NC Screw-retained abutment, TAN, angled 17, D 4.6mm, GH 2.5mm, Type B NC Screw-retained abutment, TAN, angled 30, D 4.6mm, GH 4mm, Type B NC Screw-retained abutment, TAN, angled 30, D 4.6mm, GH 4mm, Type A NC Screw-retained abutment, TAN, angled 17, D 4.6mm, GH 4mm, Type B STRAUMANN DENTAL IMPLANT SYSTEM Straumann Dental Implant System RC Healing Abutment, conical RC Healing Abutment, customizable RN Healing Cap NNC Healing Cap RC Healing Abutment , bottle NC Healing Abutment, conical NC Healing Abutment, customizable WN Healing Cap NC Healing Abutment, bottle WN Closure Cap NNC Closure Cap RC Closure Cap NC Closure Cap RN Closure Cap Roxolid BLX Implants WN Temporary Abutment, VITA CAD-Temp, PMMA RN Temporary Abutment, VITA CAD-Temp, PMMA NC Temporary Abutment, VITA CAD-Temp, PMMA RC Temporary Abutment, VITA CAD-Temp, PMMA NNC Temporary Abutment, VITA CAD-Temp, PMMA Straumann Dental Implant System Straumann Dental Implant System Straumann Dental Implant System STRAUMANN EXTRAORAL IMPLANT SYSTEM Straumann Variobase Abutments for Bridge/Bar Straumann Dental Implant System Straumann Dental Implant System Straumann Dental Implant System Straumann 4 mm Short Implants Straumann Variobase C Straumann Screw Retained Abutments Dental Implant Accesories Straumann Dental Implant System Straumann Dental Implant System NC Variobase Abutments, with screw, D 3.8mm, H 3.5mm, TAN NC Variobase®, for crown, with screw, D 3.8mm, H 5.5mm, TAN NNC Variobase Abutments, with screw, D 3.9mm, H 3.75mm, TAN RC Variobase®, for crown, with screw, D 4.5mm, H 5.5mm, TAN WN Variobase Abutments, with screw, D 7mm, H 4.5mm, TAN RC Variobase Abutments, with screw, D 4.5mm, 3.5mm, TAN WN Variobase®, for crown, with screw, D 7mm, H 6.5mm, TAN RN Variobase Abutments, with screw, D 55mm, H 4mm, TAN NNC Variobase®, for crown, with screw, D 3.9mm, H 5.75mm, TAN RN Variobase®, for crown, with screw, D 55mm, H 6mm, TAN Straumann Dental Implant System Straumann Bone Level Tapered Implant Straumann Dental Implant System Straumann Variobase Abutments TLX Implant System STRAUMANN DENTAL IMPLANT SYSTEM Straumann CARES Abutments MEMFIX Straumann Dental Implant System Straumann Dental Implant System Straumann Dental Implant System Straumann Dental Implant System Straumann BLX 3.5 mm Implants Straumann CARES Abutments Straumann Dental Implant System Narrow Neck CrossFit (NNC) Gold Abutment for Bridges Bone Level Implant TiZr RC 4.8mm L 8, 10, 12, 14mm Bone Level Implant TiZr RC 4.1mm L 8,10,12, 14mm Straumann Roxolid SLA Implants Straumann Dental Implant System Straumann Dental Implant System Straumann CARES Screw-Retained Bridges and Bars NNC Cementable Abutment, 15 degree angle Type A NNC Cementable Abutment, 15 degree angle Type B NNC Cementable Abutment, straight NNC Basel Screw for Cementable Abutments Straumann Dental Implant System Straumann Narrow Neck CrossFit (NNC) Closure Screws Straumann Narrow Neck CrossFit (NNC) Healing Caps Straumann Narrow Neck CrossFit (NNC) Temporary Abutments Straumann Narrow Neck CrossFit (NNC) Dental Implant System Straumann Narrow Neck CrossFit (NNC) Gold Abutment for Crown Straumann Dental Implant System STRAUMANN DENTAL IMPLANT SYSTEM Straumann Modular Cassette Straumann Dental Implant System Straumann Dental Implant System Taper Effect Roxolid Straumann BLX Implant System Straumann Dental Implant System STRAUMANN DENTAL IMPLANT SYSTEM Straumann Dental Implant System Straumann Dental Implant System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EHO	Bar, Preformed	Dental	Class 1	872.3165	2011-05-19
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2011-05-19
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2020-10-06
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2021-07-27
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2011-05-19
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2011-05-19
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2011-05-19
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2011-05-19
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2016-01-11
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2016-01-11
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2018-04-12
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2008-01-09
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2007-06-29
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2011-05-19
PNP	Dental Abutment Design Software For Dental Laboratory	Dental	Class 2	872.3630	2018-04-13
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2018-04-13
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2011-05-19
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2022-06-06
EJL	Bur, Dental	Dental	Class 1	872.3240	2011-05-19
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2011-05-19
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2022-04-29
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2016-03-10
PNP	Dental Abutment Design Software For Dental Laboratory	Dental	Class 2	872.3630	2025-03-03
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2025-03-03
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2015-08-26
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2011-05-19
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2011-05-19
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	1999-03-10
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2019-11-19
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2015-08-10
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2011-05-19
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2011-05-19
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2012-12-19
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2015-08-10
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2011-10-28
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2011-05-19
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2011-05-19
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2020-08-24
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2006-09-19
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2007-06-29
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2019-07-01
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2011-05-19
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2026-03-16
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2015-08-10
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2007-06-29
OAT	Implant, Endosseous, Orthodontic	Dental	Class 2	872.3640	2008-01-09
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2013-07-02
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2018-07-17
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2018-07-17
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2012-11-14
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2019-04-10
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2011-05-19
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2017-03-08
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2017-03-08
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	1999-03-10
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	1999-03-10
KCZ	Prosthesis, Breast, External, Used With Adhesive	General, Plastic Surgery	Class 1	878.3800	2007-06-29
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2015-08-06
EMH	Forceps, Rongeur, Surgical	Dental	Class 1	872.4565	2011-05-19
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2008-01-09
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2011-05-19
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2021-02-11
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2017-12-07
PNP	Dental Abutment Design Software For Dental Laboratory	Dental	Class 2	872.3630	2021-03-22
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2021-03-22
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2014-04-24
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	Class 2	880.6850	2021-07-29
NDP	Accessories, Implant, Dental, Endosseous	Dental	Class 1	872.3980	2007-06-29
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2011-05-19
EME	Punch, Biopsy, Surgical	Dental	Class 1	872.4565	2011-05-19
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2015-08-10
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2008-01-09
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2014-08-20
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2013-01-02
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2020-10-06
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2020-10-06
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2007-06-29
DZL	Screw, Fixation, Intraosseous	Dental	Class 2	872.4880	1999-03-10
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2011-05-19
EMM	Chisel, Osteotome, Surgical	Dental	Class 1	872.4565	1999-07-02
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	1999-03-10
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2011-05-19
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2022-07-13
PNP	Dental Abutment Design Software For Dental Laboratory	Dental	Class 2	872.3630	2022-07-13
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2020-01-13
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2011-05-19
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2012-02-02
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2012-06-11
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2015-07-26
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	1999-03-10
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2011-05-19
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2025-06-25
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2012-01-03
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2008-01-09
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2011-10-20
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2011-05-19
DZI	Drill, Bone, Powered	Dental	Class 2	872.4120	2011-05-19
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2007-06-29
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	Class 2	880.6850	2021-12-14
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2011-05-19
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2021-03-25
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	1999-03-10
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2011-05-19
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2022-02-11
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	1999-03-10
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2007-06-29
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2011-05-19
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2011-05-19

Official Correspondent

Andreas Petermann

US Agent Details

Jennifer M Jackson Business: Straumann USA, LLC Email: jennifer.jackson@straumann.com Phone: (978) 7472509

Related Public Records

Same Entity

INSTITUT STRAUMANN AG

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3010377510	DENTAL WINGS GMBH	Chemnitz Saxony, DE
1222315	Straumann USA, LLC	ANDOVER, MA, US
3007130440	ClearCorrect , LLC	Round Rock, TX, US
3026444199	Medentika GmbH	Calw Baden-Wurttemberg, DE
3007218081	Straumann Villeret SA	Corgemont Bern, CH

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
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
K925778	Nobelpharma USA, Inc.	BRANEMARK SYSTEM LAB. AND EDUCATIONAL ACCESSORIES	1993-04-14

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 9614404. Last updated year: 2026. Please use registration number 9614404 when referencing this establishment in official correspondence.