Data / Medical devices / Switzerland / Institut Straumann AG
Institut Straumann AG: FDA-registered device maker in BASEL Basel-Stadt, Switzerland, 152 510(k) clearances and 1 PMA approval
Institut Straumann AG is registered with the FDA (registration 9613348) in BASEL Basel-Stadt, Switzerland. It lists 26 device types. The FDA files 152 510(k) clearances and 1 PMA approval under its listings, the newest dated June 3, 2026. 1 recall event names it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 9613348
- FEI number
- 3004975279
- Address
- Peter Merian-Weg 12, BASEL Basel-Stadt, Switzerland, CH-4002
- Owner or operator
- INSTITUT STRAUMANN AG (9005052)
- Roles
- Complaint file establishment, Exporter to the US, Specification developer
- 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
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. Newest 100 of 152.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 3, 2026 | K260726 | Straumann® ProClean Cassette (041.800 ; 041.801) | KCT | Substantially Equivalent | Institut Straumann AG | accessdata.fda.gov |
| March 10, 2026 | K252168 | Straumann® BLC Implants - Indication Widening | DZE | Substantially Equivalent | Institut Straumann AG | accessdata.fda.gov |
| January 22, 2026 | K253315 | Straumann Variobase Abutments XC for Bridge/Bar | NHA | Substantially Equivalent | Institut Straumann AG | accessdata.fda.gov |
| August 12, 2025 | K250294 | Straumann® RidgeFit Implants | DZE | 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 |
| December 26, 2024 | K233252 | Straumann CARES Visual and Nova Dental CAD | PNP | 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 |
| March 20, 2024 | K234049 | Straumann® BLC and TLC Implants - Line extension | DZE | Substantially Equivalent | Institut Straumann AG | accessdata.fda.gov |
| September 14, 2023 | K230108 | Straumann® BLC and TLC Implants | DZE | Substantially Equivalent | Institut Straumann AG | accessdata.fda.gov |
| May 15, 2023 | K222836 | Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discs | NHA | Substantially Equivalent | Institut Straumann AG | accessdata.fda.gov |
| June 16, 2022 | K220878 | Straumann TLX Variobase C | NHA | 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 |
| April 8, 2022 | K213063 | TLX SRAs and TLX Gold Abutments | 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 |
| July 29, 2021 | K203753 | Straumann Surgical Cassettes | KCT | Substantially Equivalent | Straumann USA, LLC | accessdata.fda.gov |
| July 8, 2021 | K211052 | Straumann RidgeFit 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 |
| March 18, 2021 | K201681 | Straumann Immediate Temporary Abutments | NHA | Substantially Equivalent | Institut Straumann AG | accessdata.fda.gov |
| February 12, 2021 | K203355 | Straumann TLX Novaloc and Cementable Abutments | NHA | Substantially Equivalent | Institut Straumann AG | accessdata.fda.gov |
| February 12, 2021 | K192742 | Straumann Variobase C | NHA | Substantially Equivalent | Institut Straumann AG | accessdata.fda.gov |
| February 8, 2021 | K202942 | Straumann 4 mm Short Implants | DZE | Substantially Equivalent | Straumann USA, LLC | accessdata.fda.gov |
| September 24, 2020 | K201051 | Straumann BoneCeramic | LYC | 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 |
| August 13, 2020 | K193046 | Straumann® Retentive System Novaloc TiN Abutments | NHA | Substantially Equivalent | 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 |
| December 9, 2019 | K191895 | Straumann Mini Implants | DZE | Substantially Equivalent | Institut Straumann AG | accessdata.fda.gov |
| December 3, 2019 | K191522 | Straumann Modular Cassette | KCT | Substantially Equivalent | Institut Straumann AG | accessdata.fda.gov |
| October 28, 2019 | K192029 | Straumann PUREloc abutments | NHA | 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 |
| June 26, 2019 | K190097 | Straumann CARES Screw-Retained Bridges and Bars | 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 21, 2018 | K180791 | Straumann BLX Surgical Cassette | KCT | 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 |
| January 3, 2018 | K172798 | Straumann CARES Abutments CoCr | NHA | Substantially Equivalent | Institut Straumann AG | accessdata.fda.gov |
| December 1, 2017 | K171773 | Straumann n!ce Glass Ceramic A14 Blocks | NHA | Substantially Equivalent | Institut Straumann AG | accessdata.fda.gov |
| November 27, 2017 | K171757 | Straumann Screw Retained Abutments | NHA | Substantially Equivalent | Straumann USA, LLC (On Behalf of Institut Straumann Ag) | accessdata.fda.gov |
| November 14, 2017 | K173410 | n!ce for Planmill | EIH | 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 |
| March 2, 2017 | K170420 | n!ce Glass Ceramic Blocks for Amann Girrbach | EIH | Substantially Equivalent | Institut Straumann AG | accessdata.fda.gov |
| October 7, 2016 | K161677 | Straumann Sterile Healing Solution | NHA | Substantially Equivalent | Institut Straumann AG | accessdata.fda.gov |
| September 16, 2016 | K160262 | n!ce LT Glass Ceramic Blocks, n!ce HT Glass Ceramic Blocks, | EIH | Substantially Equivalent | Institut Straumann AG | accessdata.fda.gov |
| March 23, 2016 | K153758 | Straumann Bone Level Tapered Implants | DZE | Substantially Equivalent | Institut Straumann AG | accessdata.fda.gov |
| March 4, 2016 | K151590 | Straumann RN Gold Abutment for Bridge | NHA | Substantially Equivalent | Straumann USA, LLC | accessdata.fda.gov |
| January 11, 2016 | K151328 | PURE Ceramic Implants | DZE | Substantially Equivalent | Straumann USA | accessdata.fda.gov |
| September 16, 2015 | K150899 | Straumann CARES Titanium Alloy (TAN) Abutment | NHA | Substantially Equivalent | Straumann USA, LLC | accessdata.fda.gov |
| September 11, 2015 | K151324 | Straumann Variobase for CEREC | NHA | Substantially Equivalent | Straumann USA, LLC | accessdata.fda.gov |
| August 10, 2015 | K151247 | NC Straumann Screw Retained Abutments | NHA | Substantially Equivalent | Straumann USA, LLC | accessdata.fda.gov |
| August 5, 2015 | K151157 | NC Straumann Variobase Abutment for Bars/Bridges, RC Straumann Variobase Abutment for Bars/Bridges, NNC Straumann Variobase Abutment for Bars/Bridges, RN Straumann Variobase Abutment for Bars/Bridges, WN Straumann Variobase Abutment for Bars/Bridges | 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 |
| August 14, 2014 | K140737 | STRAUMANN CARES SCREW RETAINED BARS/BRIDGE | NHA | Substantially Equivalent | Straumann USA, LLC | accessdata.fda.gov |
| August 7, 2014 | K141871 | Straumann Bone Level NC Angled Screw Retained Abutments | NHA | 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 |
| January 15, 2014 | K132844 | STRAUMANN CARES BONE LEVEL SCREW RETAINED BARS, STRAUMANN CARES BONE LEVEL SCREW RETAINED BRIDGES | 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 |
| January 16, 2013 | K113246 | OCS-B | NPM | Substantially Equivalent | Nibec Company, Limited | 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 |
| November 2, 2012 | K122192 | NC TEMPORARY ABUTMENT, CAD-TEMP, PMMA RC TEMPORARY ABUTMENT, CAD-TEMP, PMMA RN TEMPORARY ABUTMENT, CAD-TEMP, PMMA WN TEM | NHA | Substantially Equivalent | Straumann USA, LLC | 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 |
| January 27, 2012 | K113606 | NNC GOLD ABUTMENT FOR BRIDGES | NHA | Substantially Equivalent | Straumann USA | accessdata.fda.gov |
| January 13, 2012 | K113410 | NNC SOLID ABUTMENT NNC TEMPORARY COPING FOR COLID ABUTMENT NNC TEMPORARY CAP FOR COLID ABUTMENT | NHA | Substantially Equivalent | Straumann USA | accessdata.fda.gov |
| December 28, 2011 | K113283 | NNC CEMENTABLE ABUTMENT STRAIGHT,15 DEGREE ANGLE, TYPE A ,15 DEGREE ANGLE, TYPE B,NNC BASAL SCREW CEMENTABLE ABUTMENTS | NHA | Substantially Equivalent | Straumann USA | accessdata.fda.gov |
| November 16, 2011 | K112280 | STRAUMANN CARES SCREW-RETAINED BRIDGE TITANIUM, STRAUMANN CARES DOLDER BAR TITANIUM | NHA | Substantially Equivalent | Straumann USA | accessdata.fda.gov |
| October 17, 2011 | K112710 | ZENOTEC ZR BRIDGE, ZENOSTAR ZR TRANSLUCENT, ZENOTEC COLOR ZR, ZENOSTAR COLOR ZR | EIH | Substantially Equivalent | Wieland Dental + Technik GmbH & Co. KG | accessdata.fda.gov |
| October 3, 2011 | K111357 | STRAUMANN NARROW NECK CROSSFIT (NNC) 03.3MM DENTAL IMPLANT SYSTEM | DZE | Substantially Equivalent | Straumann USA | accessdata.fda.gov |
| August 12, 2011 | K110580 | NARROW CONNECTION STRAUMANN ANATOMIC IPS E.MAX ABUTMENTS | NHA | Substantially Equivalent | Straumann USA | accessdata.fda.gov |
| May 4, 2011 | K102307 | GENOSS COLLAGEN MEMBRANE MODEL GCM1020, GCM3040 TOTAL 6 MODELS | NPL | Substantially Equivalent | Genoss Co., Ltd. | accessdata.fda.gov |
| December 13, 2010 | K101465 | STRAUMANN CARES BRIDGE; STRAUMANN CARES DOLDER BAR | NHA | Substantially Equivalent | Institut Straumann AG | accessdata.fda.gov |
| August 11, 2010 | K102128 | VITABLOCS | EIH | Substantially Equivalent | Vita Zahnfabrik H.Rauter GmbH & Co. | accessdata.fda.gov |
| February 12, 2010 | K093027 | STRAUMANN RC TEMPORARY ABUTMENTS | DZE | Substantially Equivalent | Straumann USA | accessdata.fda.gov |
| December 22, 2009 | K091701 | STRAUMANN MODIFIED DENTAL ABUTMENT | NHA | Substantially Equivalent | Institut Straumann AG | accessdata.fda.gov |
| December 18, 2009 | K093113 | ETKON ES1, MODEL 019.0001, ETKON VISUAL, STRAUMANN CADCAM ABUTMENT | NHA | Substantially Equivalent | Institut Straumann AG | accessdata.fda.gov |
| December 15, 2009 | K092814 | STRAUMANN DENTAL ABUTMENTS | NHA | Substantially Equivalent | Straumann Manufacturing, Inc. | accessdata.fda.gov |
| May 22, 2009 | K082111 | STRAUMANN MEMBRAGEL | NPK | Substantially Equivalent | Institut Straumann AG | accessdata.fda.gov |
| February 26, 2009 | K090260 | MODIFICATION TO:STRAUMANN GUIDED INSTRUMENTS | DZE | Substantially Equivalent | Straumann Manufacturing, Inc. | accessdata.fda.gov |
| February 26, 2009 | K083550 | STRAUMANN DENTAL IMPLANT SYSTEM | DZE | Substantially Equivalent | Straumann USA | accessdata.fda.gov |
| February 20, 2009 | K081419 | STRAUMANN DENTAL IMPLANT SYSTEM | DZE | Substantially Equivalent | Institut Straumann AG | accessdata.fda.gov |
| October 21, 2008 | K082532 | STRAUMANN GUIDED INSTRUMENTS | DZI | Substantially Equivalent | Straumann USA | accessdata.fda.gov |
| October 17, 2008 | K082545 | STRAUMANN NN CARES TITANIUM AND CERAMIC ABUTMENTS | NHA | Substantially Equivalent | Institut Straumann AG | accessdata.fda.gov |
| October 1, 2008 | K082764 | STRAUMANN WN CARES TITANIUM ABUTMENT | NHA | Substantially Equivalent | Institut Straumann AG | accessdata.fda.gov |
| May 2, 2008 | K081005 | P.004 NC CARES TITANIUM AND CERAMIC ABUTMENTS | NHA | Substantially Equivalent | Institut Straumann AG | accessdata.fda.gov |
| April 30, 2008 | K080239 | P.004 ABUTMENTS, P.004 TEMPORARY COPINGS, P.004 PROTECTIVE CAPS, P.004 PERMANENT COPINGS | NHA | Substantially Equivalent | Straumann Manufacturing, Inc. | accessdata.fda.gov |
| March 7, 2008 | K080286 | CEMENTABLE ABUNTMENTS; TEMPORARY COPINGS; PROTECTIVE CAPS | NHA | Substantially Equivalent | Straumann USA | accessdata.fda.gov |
| January 22, 2008 | K073628 | SYNOCTA ABUTMENTS | NHA | Substantially Equivalent | Straumann USA | accessdata.fda.gov |
| October 15, 2007 | K071888 | STRAUMANN P.004 RC GOLD ABUTMENT FOR BRIDGES | NHA | Substantially Equivalent | Straumann USA | accessdata.fda.gov |
| October 12, 2007 | K072679 | P.004 ABUTMENTS | NHA | Substantially Equivalent | Institut Straumann AG | accessdata.fda.gov |
| September 26, 2007 | K072497 | P.004 NC GOLD ABUTMENT FOR CROWNS | NHA | Substantially Equivalent | Institut Straumann AG | accessdata.fda.gov |
| September 26, 2007 | K071919 | P.004 ABUTMENTS | NHA | Substantially Equivalent | Straumann USA (On Behalf of Institut Straumann Ag) | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| September 30, 1996 | P930021 | BIORA EMDOGAIN(R) | NQA | 34 | September 5, 2025 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| September 28, 2007 | 45420 | Not yet classified | Terminated | Straumann Palatal Implant, 04.1 L 4.2 mm, Article Number: 042.335S, Straumann USA., LLC, Andover, Massachusetts, 01810-1008 | Sticking Transfer Piece: The Transfer Piece which accompanies the Palatal Implant may get stuck during implant requiring removal by using mechanical force. | accessdata.fda.gov |
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Updated June 3, 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.