Data / Medical devices / France / Anthogyr
Anthogyr: FDA-registered device maker in SALLANCHES Haute-Savoie, France, 18 510(k) clearances
Anthogyr is registered with the FDA (registration 8020776) in SALLANCHES Haute-Savoie, France. It lists 25 device types. The FDA files 18 510(k) clearances under its listings, the newest dated August 12, 2025. 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
- 8020776
- FEI number
- 4224
- Address
- 2237, Avenue Andre Lasquin, SALLANCHES Haute-Savoie, France, 74700
- Owner or operator
- INSTITUT STRAUMANN AG (9005052)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- July 2, 1999
- Registered through
- 2027
- Brand names listed
- ASPEO, Anthogyr ACCESSOIRIES, Anthogyr ATD AUTOMATIC BRIDGE REMOVER, Anthogyr SAFE RELAX, Anthogyr SAFE REMOVER, Avenue L Lumbar Cage, CONTRE-ANGLES, Dental Implant Accesories 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.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 12, 2025 | K250294 | Straumann® RidgeFit Implants | DZE | Substantially Equivalent | Institut Straumann AG | accessdata.fda.gov |
| January 4, 2024 | K231072 | Anthogyr FlexiBase® titanium bases for Axiom® BL | NHA | Substantially Equivalent | Anthogyr | accessdata.fda.gov |
| December 22, 2023 | K233264 | Anthogyr INTEGRAL Guided Surgery Cassettes | KCT | Substantially Equivalent | Anthogyr | accessdata.fda.gov |
| October 16, 2023 | K230104 | Anthogyr AXIOM® BL X3 implants, Anthogyr Multi-Unit components for AXIOM® BL | DZE | Substantially Equivalent | Anthogyr | accessdata.fda.gov |
| July 11, 2023 | K230680 | Anthogyr Surgical Cassettes | KCT | Substantially Equivalent | Anthogyr | accessdata.fda.gov |
| July 8, 2021 | K211052 | Straumann RidgeFit 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 |
| June 15, 2017 | K161177 | Axiom PX | DZE | Substantially Equivalent | Anthogyr Sas | accessdata.fda.gov |
| April 27, 2017 | K160730 | Instrument kits | KCT | Substantially Equivalent | Anthogyr | accessdata.fda.gov |
| September 17, 2014 | K141450 | AXIOM 2.8 | DZE | Substantially Equivalent | Anthogyr Sas | accessdata.fda.gov |
| February 21, 2014 | K131066 | AXIOM REG | DZE | Substantially Equivalent | Anthogyr Sas | accessdata.fda.gov |
| October 7, 2011 | K111532 | MONTBLANC SURGICAL CONTRA-ANGLE AND STRAIGHT HANDPIECE | EGS | Substantially Equivalent | Anthogyr Sas | accessdata.fda.gov |
| March 23, 2011 | K102241 | ANTHOGYR IMPLANTEO IMPLANTOLOGY AND DENTAL SURGICAL MOTOR UNIT | EBW | Substantially Equivalent | Anthogyr Sas | accessdata.fda.gov |
| March 11, 2011 | K101913 | ANTHOFIT OI, ANTHOFIT HE, OSSFIT AND AXIOM | DZE | Substantially Equivalent | Anthogyr Sas | accessdata.fda.gov |
| March 3, 2010 | K093894 | ANTHOGYR IMPULSION IMPLANTOLOGY CONTRA-ANGLE | EFA | Substantially Equivalent | Anthogyr | accessdata.fda.gov |
| May 22, 2009 | K090676 | MONTBLANC IMPLANTOLOGY AND OMNIPRATIQUE CONTRA-ANGLES | EFA | Substantially Equivalent | Anthogyr | accessdata.fda.gov |
| June 30, 2004 | K040674 | IMPLANTOLOGY CONTRA ANGLES, ENDODONTIC CONTRA ANGLES, GENERAL DENTISTRY CONTRA ANGLES | EFA | Substantially Equivalent | Anthogyr | accessdata.fda.gov |
| July 3, 2002 | K020431 | FIBIOCORE | ELR | Substantially Equivalent | Est. Anthogyr | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| June 20, 2016 | 74722 | Class II | Terminated | Axiom REG implants Sterile The Axiom REG implants are used as artificial root structures for replacement of missing teeth. They can be used for stabilization of removable prostheses or fixation of single tooth restoratio | Following a FDA inspection showing that the firm failed to validate the design and process of its implants. | accessdata.fda.gov |
Compare with other makers
- All makers of Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
- All makers of Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
- All makers of Needle, Dental
- All makers of Intervertebral Fusion Device With Bone Graft, Lumbar
- All makers of Implant, Endosseous, Root-Form
- All makers of Post, Root Canal
Updated August 12, 2025. 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.