INSTITUT STRAUMANN AG

FDA Device Registration & Listing · BASEL Basel-Stadt, CH · Registration 9613348

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
9613348
FEI Number
3004975279
Entity Name
INSTITUT STRAUMANN AG
City/State/Country
BASEL Basel-Stadt, CH
Establishment Address
PETER MERIAN-WEG 12, BASEL Basel-Stadt CH-4002, CH
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
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
N
Expiration Date (Year)
2026
510(k) Number
K243278
PMA Number
N/A

All Registered Proprietary Names

Straumann Dental Implant System Straumann Dental Implant System WN Gold Abutment, for Bridge RN Gold Abutment, for Bridge Straumann Dental Implant System Straumann BoneCeramic Straumann CARES Screw-Retained Bridges and Bars Straumann 4 mm Short Implants Straumann Screw Retained Abutments Straumann PURE Ceramic Implants zerion and glass ceramic restorations 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 Variobase C Straumann Dental Implant System TLC Implants BLC Implants Straumann Roxolid SLA Implants Straumann Dental Implant System STRAUMANN DENTAL IMPLANT SYSTEM Straumann Dental Implant System Straumann Dental Implant System ticon and coron restorations Straumann® Retentive System – Novaloc TiN Abutments Straumann CARES Abutments Straumann Dental Implant System Straumann ProClean™ Cassette Straumann Dental Implant System Straumann CARES Screw-Retained Bridge and Dolder Bar zerion HT elements STRAUMANN DENTAL IMPLANT SYSTEM STRAUMANN BONE CERAMIC STRAUMANN BONECERAMIC Straumann Dental Implant System Roxolid BLX Implants NC Healing Abutment Straumann Dental Implant System Straumann Variobase Abutments for Bridge/Bar Straumann Dental Implant System Straumann Variobase for CEREC Variobase for CEREC STRAUMANN DENTAL IMPLANT SYSTEM Straumann CARES Abutments TLX Screw-Retained Abutments 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 Straumann Dental Implant System NNC Solid Abutment NNC Temporary Coping NNC Protective Cap STRAUMANN DENTAL IMPLANT SYSTEM Bone Level Implant TiZr RC 4.8mm L 8, 10, 12, 14mm Bone Level Implant TiZr RC 4.1mm L 8,10,12, 14mm 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 Membrane Max Straumann CARES Abutments Straumann Dental Implant System IPS Empress CAD Straumann® BLX Temporary Abutment, VITA CAD-Temp, PMMA Straumann Dental Implant System Straumann Dental Implant System Straumann Variobase Abutments Straumann Dental Implant System 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 S300W Straumann CARES Visual Chairside DWOS Straumann CARES Visual AS260 ST200E ST 300E DI-1 Smart Design SIRIOS AS200E Straumann Dental Implant System Straumann Dental Implant System Straumann Dental Implant System Straumann Dental Implant System synOcta abutment Screw Retained Abutments Straumann Dental Implant System Straumann BLX Surgical Cassette polyamide restoration Straumann Dental Implant System CARES TAN Abutment Straumann CARES TAN Abutment Straumann CARES Abutments Straumann Dental Implant System Straumann BLX Gold Abutment STRAUMANN DENTAL IMPLANT SYSTEM Straumann Dental Implant System Straumann BLX Implant System Straumann Dental Implant System Straumann Modular Cassette Straumann Dental Implant System Straumann Dental Implant System Porcelain powder Novaloc Equator Attachment Optiloc 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 Straumann Variobase for Crown AS Neodent Titanium Block for Medentika Holder Straumann Pre-Milled Abutment Blank for Medentika Holder Straumann InLab Validated Workflow STRAUMANN DENTAL IMPLANT SYSTEM TLX Implant System Straumann Dental Implant System 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 Strauamnn CARES Dolder Bar Titanium Straumann CARES Screw-retained Bridge Titanium Straumann CARES Abutments Straumann CARES CS2 Scanner CARES Abutment MEMFIX Straumann PUREloc Abutments Straumann Bone Level Tapered Implant Straumann Dental Implant System Straumann Dental Implant System 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 Straumann Dental Implant System Straumann Dental Implant System Narrow Neck CrossFit (NNC) Gold Abutment for Bridges Straumann Dental Implant System Straumann Dental Implant System STRAUMANN EMDOGAIN Straumann® RidgeFit Implants MEMFIX Straumann Anatomic Healing Abutments Pre-milled Abutment Blank for CARES® 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 NNC Closure Screw, H0 (4-pack) RC Healing Abutment, conical diameter 6, H4 NC Closure Cap for Fixation Cap, Ti RC Healing Abutment, conical diameter 6, H6 RN Closure Cap, H1.5, Ti (4-pack) NNC Closure Screw, H0 RC Closure Screw, H0 RC Healing Abutment, conical diameter 4.5, H6 NC Fixation Cap, Ti NC Closure & Fixation Cap, diameter 5.5mm, Ti RC Closure & Fixation Cap, diameter 5.5mm, Ti RC Closure Screw, H0 (4-pack) RC Closure Cap for Fixation Cap, Ti NC Closure Screw, H0 (4-pack) RC Closure Screw, H0.5 RC Closure Screw, H0.5 (4-pack) RC Fixation Cap, Ti RN closure Cap, H0, Ti (4-pack) NNC Closure Screw, H0.5 (4-pack) RC Healing Abutment, conical diameter 4.5, H4 NNC Closure Screw, H0.5 NC Closure Screw, H0 NC Closure Screw, H0.5 (4-pack) RC Healing Abutment, conical diameter 4.5, H2 NC Closure Screw, H0.5 RC Healing Abutment, conical diameter 6, H2 Taper Effect Roxolid Straumann Dental Implant System Straumann Dental Implant System Dental Implant Accesories Straumann Dental Implant System Straumann Dental Implant System n!ce Crown n!ce Inlay n!ce Partial Crown n!ce Veneer n!ce Onlay Straumann Dental Implant System Straumann XenoGraft Variobase® XC for Bridge/Bar, Variobase® XC for Bridge/Bar AS Straumann Custom Abutment AS

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2008-01-09
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2011-05-19
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2016-03-10
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2011-05-19
LYC Bone Grafting Material, Synthetic Dental Class 2 872.3930 2021-12-14
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2025-06-25
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2021-02-11
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2014-04-24
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
EIH Powder, Porcelain Dental Class 2 872.6660 2008-02-20
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
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
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 1999-03-10
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2024-04-11
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2019-03-27
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2015-07-26
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 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 2021-07-29
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
EJH Alloy, Metal, Base Dental Class 2 872.3710 2008-03-12
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2020-08-26
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2011-05-19
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2026-06-05
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2017-12-07
EIH Powder, Porcelain Dental Class 2 872.6660 2011-05-19
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2011-07-07
EIH Powder, Porcelain Dental Class 2 872.6660 2013-02-22
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2007-06-29
LYC Bone Grafting Material, Synthetic Dental Class 2 872.3930 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 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 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 2015-08-06
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2020-07-07
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2008-01-09
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2015-09-14
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2007-06-29
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2021-03-25
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2022-04-29
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2021-07-29
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2013-07-02
EMM Chisel, Osteotome, Surgical Dental Class 1 872.4565 1999-07-02
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2012-01-18
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2007-06-29
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2012-06-11
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2012-11-14
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2011-05-19
NPL Barrier, Animal Source, Intraoral Dental Class 2 872.3930 2014-08-21
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
EIH Powder, Porcelain Dental Class 2 872.6660 2011-12-08
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2022-06-06
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 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 2013-01-02
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 1999-03-10
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2006-09-19
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
NOF System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations Dental Class 2 872.3661 2008-01-24
EJX Anchor, Preformed Dental Class 1 872.3130 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
OAT Implant, Endosseous, Orthodontic Dental Class 2 872.3640 2008-01-09
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2011-05-19
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2019-01-08
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2019-01-08
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2020-10-06
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
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2018-07-17
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2010-01-07
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 1999-03-10
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2015-09-16
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 2007-06-29
EHO Bar, Preformed Dental Class 1 872.3165 2011-05-19
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2022-02-11
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2011-05-19
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2021-12-14
EMH Forceps, Rongeur, Surgical Dental Class 1 872.4565 2011-05-19
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2011-05-19
EIH Powder, Porcelain Dental Class 2 872.6660 2011-07-15
EGG Attachment, Precision, All Dental Class 1 872.3165 2021-08-03
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 2018-04-12
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 2007-06-29
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
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 1999-03-10
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2015-08-10
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2011-05-19
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2019-07-01
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2011-05-19
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2011-11-18
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2010-01-07
NOF System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations Dental Class 2 872.3661 2011-01-25
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2011-01-25
DZL Screw, Fixation, Intraosseous Dental Class 2 872.4880 1999-03-10
EIH Powder, Porcelain Dental Class 2 872.6660 2023-05-22
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2023-05-22
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2019-11-19
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2014-08-20
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 1999-03-10
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2015-08-10
EJL Bur, Dental Dental Class 1 872.3240 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 2012-02-02
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2008-01-09
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2018-01-29
EIH Powder, Porcelain Dental Class 2 872.6660 2017-03-13
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2008-01-09
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2008-01-09
NQA Biologic Material, Dental Dental Class 3 872.3930 2006-12-06
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2026-04-21
DZL Screw, Fixation, Intraosseous Dental Class 2 872.4880 1999-03-10
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
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2024-11-15
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
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
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2012-01-03
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2016-10-17
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2011-05-19
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
NDP Accessories, Implant, Dental, Endosseous Dental Class 1 872.3980 2007-06-29
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
EIH Powder, Porcelain Dental Class 2 872.6660 2016-11-09
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2011-05-19
NPM Bone Grafting Material, Animal Source Dental Class 2 872.3930 2014-08-21
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2026-02-13
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2025-03-03

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
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
K903999 O Co., Inc. OBUTMENT HB 1992-02-11

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
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
Z-0029-05 Implant Innovations, Inc. 2
EP Healing Abutment- An abutment device is a premanufactured prosthetic component directly connected to the endosseous dental implant.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9613348. Last updated year: 2026. Please use registration number 9613348 when referencing this establishment in official correspondence.
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