510(k) Report

FDA applicant

Anthogyr

Sallanches, FR16 decisions2004–20242 recalls

FDA records 16 decisions for Anthogyr (Sallanches, FR) from 2004 to 2024: 16 510(k) clearances. Most are in product codes DZE (Implant, Endosseous, Root-Form) and KCT (Sterilization Wrap Containers, Trays…). Since 2016 its 510(k)s took a median of 271 days from receipt to decision, against 185 for FDA’s reviews in the same codes and years. Its devices cite 41 predicates, 11 of them its own earlier devices. 2 recalls are linked to its devices.

FDA’s records also spell it “Anthogyr Sas”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, dental panel, where it files most

How often FDA has decided Anthogyr’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2009: 12010: 12011: 32014: 22017: 22023: 32024: 1
2007high 3 (2011) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

2in 2016

2016: 2
2007high 2 (2016) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Anthogyr by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • DZEImplant, Endosseous, Root-Form5decisions
  • KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories3decisions
  • EFAHandpiece, Belt And/Or Gear Driven, Dental3decisions
  • NHAAbutment, Implant, Dental, Endosseous1decision
  • EKXHandpiece, Direct Drive, Ac-Powered1decision
  • EGSHandpiece, Contra- And Right-Angle Attachment, Dental1decision

Also: EJI (1), EBW (1).

How long do its 510(k) reviews take?

Since 2016, its 6 510(k)s took a median of 271 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 185 days; 1 of its 6 were faster than that.

Whose devices does it build on?

Its devices cite 41 predicates; 11 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 19 times; 11 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K040674Implantology Contra Angles, Endodontic Contra Angles, General Dentistry Contra AnglesAnthogyr · 20045cite it
  • K101913Anthofit OI, Anthofit HE, Ossfit and AxiomAnthogyr Sas · 20113cite it
  • K160730Instrument kitsAnthogyr · 20172cite it
  • K131066Axiom RegAnthogyr Sas · 20142cite it
  • K040671Eroject, Miniject, Self Aspirating Syringes, Aspirating Syringes, Non Aspirating SyringesAnthogyr · 20042cite it
  • K090676Montblanc Implantology and Omnipratique Contra-AnglesAnthogyr · 20092cite it

What has FDA decided for it lately?

  • K231072Anthogyr FlexiBase® titanium bases for Axiom® BLAnthogyr · 2024
  • K233264Anthogyr INTEGRAL Guided Surgery CassettesAnthogyr · 2023
  • K230104Anthogyr AXIOM® BL X3 implants, Anthogyr Multi-Unit components for AXIOM® BLAnthogyr · 2023
  • K230680Anthogyr Surgical CassettesAnthogyr · 2023
  • K161177Axiom PXAnthogyr Sas · 2017
  • K160730Instrument kitsAnthogyr · 2017
  • K141450AXIOM 2.8Anthogyr Sas · 20141 recall
  • K131066Axiom RegAnthogyr Sas · 2014

All 10 as Anthogyr →All 6 as Anthogyr Sas →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K141450Axiom 2.8 implants Sterile The Axiom REG implants are used as artificial root structures…Jun 20, 2016Class II
  • K101913Axiom REG implants Sterile The Axiom REG implants are used as artificial root structures…Jun 20, 2016Class II