Straumann Manufacturing, Inc.

FDA Device Registration & Listing · Andover, MA, US · Registration 3033781108

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
3033781108
FEI Number
3033781108
Entity Name
Straumann Manufacturing, Inc.
City/State/Country
Andover, MA, US
Establishment Address
60 Minuteman Road, Andover, MA 01810, US
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
N
Expiration Date (Year)
2026
510(k) Number
K200586
PMA Number
N/A

All Registered Proprietary Names

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 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 Dental Implant System Straumann Anatomic Healing Abutments Straumann Variobase Abutments Roxolid BLX Implants 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 Straumann Dental Implant System 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 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 CARES Abutments Straumann Dental Implant System Straumann CARES Abutments Straumann Dental Implant System Straumann Dental Implant System STRAUMANN DENTAL IMPLANT SYSTEM Straumann Dental Implant System Straumann Variobase C Straumann Dental Implant System Straumann Dental Implant System 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 Straumann Dental Implant System Straumann Dental Implant System Dental Implant Accesories Straumann Dental Implant System Straumann BLX 3.5 mm Implants Straumann Dental Implant System TLX Implant System

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 2019-01-08
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2019-01-08
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 2015-08-10
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
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2012-12-19
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 1999-03-10
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2019-04-10
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2024-11-15
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2013-01-02
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 2016-10-17
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2008-01-09
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 2008-01-09
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2008-01-09
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2012-06-11
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
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2011-05-19
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2006-09-19
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 1999-03-10
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 2019-01-14
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2019-01-14
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 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 2013-07-02
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
NDP Accessories, Implant, Dental, Endosseous Dental Class 1 872.3980 2007-06-29
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 1999-03-10
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2020-01-13
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2008-01-09
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

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

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 3033781108. Last updated year: 2026. Please use registration number 3033781108 when referencing this establishment in official correspondence.
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