Data / Medical devices / United States / Straumann Manufacturing, Inc.
Straumann Manufacturing, Inc.: FDA-registered device maker in Andover, MA, United States, 61 510(k) clearances
Straumann Manufacturing, Inc. is registered with the FDA (registration 3033781108) in Andover, MA, United States. It lists 4 device types. The FDA files 61 510(k) clearances under its listings, the newest dated January 22, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3033781108
- Address
- 60 Minuteman Road, Andover, MA, United States, 01810
- Owner or operator
- INSTITUT STRAUMANN AG (9005052)
- Roles
- Manufacturer
- First device listed
- March 10, 1999
- Registered through
- 2027
- Brand names listed
- 033.530S Standard TL, RN, Ø4.1mm, SLActive 6mm, TiZr, 033.531S Standard TL, RN, Ø4.1mm, SLActive 8mm, TiZr, 033.532S Standard TL, RN, Ø4.1mm, SLActive 10mm, TiZr, 033.533S Standard TL, RN, Ø4.1mm, SLActive 12mm, TiZr, 033.534S Standard TL, RN, Ø4.1mm, SLActive 14mm, TiZr, 033.535S Standard TL, RN, Ø4.1mm, SLActive 16mm, TiZr, 033.560S Standard Plus TL, RN, Ø4.1mm, SLActive 6mm, TiZr, 033.561S Standard Plus TL, RN, Ø4.1mm, SLActive 8mm, TiZr and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Abutment, Implant, Dental, Endosseous | NHA | 2 | Manufacturer | accessdata.fda.gov |
| Accessories, Implant, Dental, Endosseous | NDP | 1 | Manufacturer | accessdata.fda.gov |
| Dental Abutment Design Software For Dental Laboratory | PNP | 2 | Manufacturer | accessdata.fda.gov |
| Implant, Endosseous, Root-Form | DZE | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 22, 2026 | K253315 | Straumann Variobase Abutments XC for Bridge/Bar | NHA | Substantially Equivalent | Institut Straumann AG | accessdata.fda.gov |
| February 21, 2025 | K243278 | Custom Abutments | NHA | Substantially Equivalent | Institut Straumann AG | accessdata.fda.gov |
| February 19, 2025 | K243478 | Straumann InLab Validated Workflow | NHA | Substantially Equivalent | Institut Straumann AG | accessdata.fda.gov |
| November 11, 2024 | K241575 | Straumann® Anatomic Healing Abutments XC (AHA) | NHA | Substantially Equivalent | Straumann USA, LLC | accessdata.fda.gov |
| September 14, 2023 | K230108 | Straumann® BLC and TLC Implants | DZE | Substantially Equivalent | Institut Straumann AG | accessdata.fda.gov |
| June 2, 2022 | K220751 | Straumann BLX Temporary Abutment, VITA CAD-Temp, PMMA | NHA | Substantially Equivalent | Institut Straumann AG | accessdata.fda.gov |
| January 28, 2022 | K212533 | BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) Implants | DZE | Substantially Equivalent | Institut Straumann AG | accessdata.fda.gov |
| June 21, 2021 | K210855 | Straumann BLX Implant System | DZE | Substantially Equivalent | Institut Straumann AG | accessdata.fda.gov |
| February 12, 2021 | K192742 | Straumann Variobase C | NHA | Substantially Equivalent | Institut Straumann AG | accessdata.fda.gov |
| August 20, 2020 | K200586 | Straumann TLX Implant System | DZE | Substantially Equivalent | Institut Straumann AG | accessdata.fda.gov |
| August 19, 2020 | K200597 | Straumann BLX Gold Abutments | NHA | Substantially Equivalent | Straumann USA, LLC (On Behalf of Institut Straumann Ag) | accessdata.fda.gov |
| April 6, 2020 | K192401 | Straumann Screw-Retained Abutments | NHA | Substantially Equivalent | Straumann USA, LLC | accessdata.fda.gov |
| January 3, 2020 | K192893 | Straumann Ceramic Healing Abutments | NHA | Substantially Equivalent | Institut Straumann AG | accessdata.fda.gov |
| December 27, 2019 | K191256 | Straumann BLX Ø3.5 mm Implants | DZE | Substantially Equivalent | Institut Straumann AG | accessdata.fda.gov |
| June 28, 2019 | K190654 | Straumann CI RD Ceramic Healing Caps | NHA | Substantially Equivalent | Institut Straumann AG | accessdata.fda.gov |
| April 8, 2019 | K190040 | Straumann BLX Line Extension - New Abutments | NHA | Substantially Equivalent | Institut Straumann AG | accessdata.fda.gov |
| January 4, 2019 | K180477 | Straumann PURE Ceramic Implant System | DZE | Substantially Equivalent | Institut Straumann AG | accessdata.fda.gov |
| December 28, 2018 | K181703 | Straumann BLX Line Extension - Implants, SRAs and Anatomic Abutments | DZE | Substantially Equivalent | Institut Straumann AG | accessdata.fda.gov |
| July 17, 2018 | K173968 | Straumann Variobase for Bridge/Bar Cylindrical | NHA | Substantially Equivalent | Institut Straumann AG | accessdata.fda.gov |
| June 5, 2018 | K173961 | Straumann BLX Implant System | DZE | Substantially Equivalent | Institut Straumann AG | accessdata.fda.gov |
| March 30, 2018 | K173379 | Straumann Variobase for Crown AS | NHA | Substantially Equivalent | Institut Straumann AG | accessdata.fda.gov |
| February 22, 2018 | K171649 | Straumann CARES M-Series CAD/CAM System | NHA | Substantially Equivalent | Institut Straumann AG | accessdata.fda.gov |
| March 8, 2017 | K162890 | BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing Abutments, SC Temporary Abutments, SC Variobase Abutments, SC CARES Abutment | DZE | Substantially Equivalent | Straumann USA, LLC | accessdata.fda.gov |
| October 7, 2016 | K161677 | Straumann Sterile Healing Solution | NHA | Substantially Equivalent | Institut Straumann AG | accessdata.fda.gov |
| September 16, 2015 | K150899 | Straumann CARES Titanium Alloy (TAN) Abutment | NHA | Substantially Equivalent | Straumann USA, LLC | accessdata.fda.gov |
| July 24, 2015 | K150938 | Straumann® Dental Implant System ¿ Roxolid® SLA Implants | DZE | Substantially Equivalent | Straumann USA, LLC | accessdata.fda.gov |
| January 9, 2015 | K142890 | Straumann Variobase Abutment NNC, Straumann Variobase Abutment RN, Straumann Variobase Abutment WN, Straumann Variobase Abutment NC, Straumann Variobase Abutment RC, IPS e.max CAD MO Coping, IPS e.max CAD LT Crown, IPS e.max CAD HT Crown, coron CoCr Single Unit | NHA | Substantially Equivalent | Straumann USA, LLC | accessdata.fda.gov |
| August 20, 2014 | K140878 | STRAUMANN BONE LEVEL TAPERED IMPLANT | DZE | Substantially Equivalent | Straumann USA, LLC | accessdata.fda.gov |
| April 17, 2014 | K133421 | STRAUMANN MAGELLAN(TM) ABUTMENT,PROTECTIVE CAP,TITANIUM COPINGS,GOLD CHOPINGS,BASAL SCREW | NHA | Substantially Equivalent | Straumann USA, LLC | accessdata.fda.gov |
| February 21, 2014 | K132219 | STRAUMANN(R) VARIOBASE(TM) ABUTMENT NNC, STRAUMANN(R) VARIOBASE(TM) ABUTMENT RN, STRAUMANN(R) VARIOBASE(TM) ABUTMENT WN, | NHA | Substantially Equivalent | Straumann USA, LLC | accessdata.fda.gov |
| June 28, 2013 | K130808 | STRAUMANN HEALING ABUTMENTS, HEALING CAPS, CLOSURE SCREWS | NHA | Substantially Equivalent | Straumann USA | accessdata.fda.gov |
| December 21, 2012 | K120822 | STRAUMANN CARES VARIOBASE ABUTMENT NNC, STRAUMANN CARES VARIOBASE ABUTMENT RN, STRAUMANN CARES VARIOBASE ABUTMENT WN, ST | NHA | Substantially Equivalent | Institut Straumann AG | accessdata.fda.gov |
| December 12, 2012 | K122855 | TL 04.1MM RN,S, SLACTIVE TIZR 6, 8, 10, 12, 14, 16MM DENTAL IMPLANTS | DZE | Substantially Equivalent | Straumann USA | accessdata.fda.gov |
| June 6, 2012 | K121131 | BL, 04.1 MM RC, SLACTIVE 8MM, TIZR AND 10MM, 12, 14MM | DZE | Substantially Equivalent | Straumann USA | accessdata.fda.gov |
| February 12, 2010 | K093027 | STRAUMANN RC TEMPORARY ABUTMENTS | DZE | Substantially Equivalent | Straumann USA | accessdata.fda.gov |
| December 15, 2009 | K092814 | STRAUMANN DENTAL ABUTMENTS | NHA | Substantially Equivalent | Straumann Manufacturing, Inc. | accessdata.fda.gov |
| February 26, 2009 | K083550 | STRAUMANN DENTAL IMPLANT SYSTEM | DZE | Substantially Equivalent | Straumann USA | accessdata.fda.gov |
| May 2, 2008 | K081005 | P.004 NC CARES TITANIUM AND CERAMIC ABUTMENTS | NHA | Substantially Equivalent | Institut Straumann AG | accessdata.fda.gov |
| September 11, 2007 | K072151 | P.004 RC CARES TITANIUM AND CERAMIC ABUTMENTS | NHA | Substantially Equivalent | Straumann USA | accessdata.fda.gov |
| August 15, 2007 | K072071 | STRAUMANN P.004 CEMENTABLE ABUTMENTS, TEMPORARY COPINGS AND PROTECTIVE CAPS | NHA | Substantially Equivalent | Institut Straumann AG | accessdata.fda.gov |
| July 11, 2007 | K071585 | P.004 HEALING ABUTMENTS AND CLOSURE SCREWS | NHA | Substantially Equivalent | Straumann USA | accessdata.fda.gov |
| October 20, 2006 | K062129 | P.0004 IMPLANTS | DZE | Substantially Equivalent | Institut Straumann AG | accessdata.fda.gov |
| August 11, 2006 | K061176 | STRAUMANN DENTAL IMPLANTS | DZE | Substantially Equivalent | Institut Straumann AG | accessdata.fda.gov |
| February 27, 2006 | K053088 | SLACTIVE IMPLANTS | DZE | Substantially Equivalent | Institut Straumann AG | accessdata.fda.gov |
| July 23, 2004 | K041070 | STRAUMANN TEMPORARY COPING | NHA | Substantially Equivalent | The Straumann Co. | accessdata.fda.gov |
| June 30, 2004 | K033984 | STRAUMANN DENTAL IMPLANT SYSTEM | DZE | Substantially Equivalent | Institut Straumann AG | accessdata.fda.gov |
| January 7, 2004 | K033922 | MODIFICATION TO ITI DENTAL IMPLANT SYSTEM | DZE | Substantially Equivalent | Institut Straumann AG | accessdata.fda.gov |
| December 19, 2001 | K013798 | PROSTHETIC ACCESSORIES TO THE ITI DENTAL IMPLANT SYSTEM | DZE | Substantially Equivalent | Institut Straumann AG | accessdata.fda.gov |
| August 22, 2001 | K012757 | ITI DENTAL IMPLANT SYSTEM | DZE | Substantially Equivalent | Straumann USA | accessdata.fda.gov |
| August 17, 2001 | K003552 | ITI DENTAL IMPLANT SYSTEM | DZE | Substantially Equivalent | Institut Straumann SA | accessdata.fda.gov |
| May 10, 2001 | K010291 | ITI DENTAL IMPLANT SYSTEM | DZE | Substantially Equivalent | Straumann USA | accessdata.fda.gov |
| March 20, 2001 | K003271 | MODIFICATION TO ITI DENTAL IMPLANT SYSTEM | DZE | Substantially Equivalent | Institut Straumann AG | accessdata.fda.gov |
| March 17, 2000 | K994119 | SYNOCTA ANGLED ABUTMENTS | DZE | Substantially Equivalent | Straumann USA | accessdata.fda.gov |
| July 20, 1999 | K990342 | SYNOCTA PROSTHETICS | DZE | Substantially Equivalent | Straumann USA | accessdata.fda.gov |
| May 13, 1999 | K984104 | ITI DENTAL IMPLANT SYSTEM | DZE | Substantially Equivalent | Straumann USA | accessdata.fda.gov |
| March 15, 1999 | K983742 | ITI DENTAL IMPLANT SYSTEM | DZE | Substantially Equivalent | Institut Straumann AG | accessdata.fda.gov |
| December 2, 1997 | K973353 | BONDING BASE | DZE | Substantially Equivalent | Straumann USA | accessdata.fda.gov |
| June 30, 1997 | K971578 | ENDOSSEOUS DENTAL IMPLANT | DZE | Substantially Equivalent | Straumann USA | accessdata.fda.gov |
| October 7, 1996 | K962647 | ANGLED ABUTMENT | DZE | Substantially Equivalent | Straumann USA | accessdata.fda.gov |
| June 18, 1996 | K960634 | TITANIUM HEALING CAPS | DZE | Substantially Equivalent | The Straumann Co. | accessdata.fda.gov |
| February 2, 1990 | K894844 | BONEFIT IMPLANT SYSTEM ACCESSORIES & INSTRUMENTS | DZE | Substantially Equivalent | Straumann Institute, Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Implant, Endosseous, Root-Form
- All makers of Abutment, Implant, Dental, Endosseous
- All makers of Accessories, Implant, Dental, Endosseous
- All makers of Dental Abutment Design Software For Dental Laboratory
Updated January 22, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.