AXIOM 2.8— 510(k) K141450

Clearance details

Applicant

Anthogyr Sas

Product code

Code DZE

Device class

Class 2

Regulation

21 CFR 872.3640

Advisory panel

Dental

Date received

2014-06-02

Decision date

2014-09-17

Decision

Substantially Equivalent

Clearance type

Abbreviated

Location

Sallanches, FR

• K260463 — ZEROS Dental Implant System2026-08-19
• K251188 — UNIQA® Dental Implants System2026-06-25
• K250806 — Dental Implant System2026-06-18
• K251232 — MegaGen Zygoma Dental Implant System2026-06-18
• K260006 — INOSS System2026-06-17

• K161177 — Axiom PX2017-06-15
• K131066 — AXIOM REG2014-02-21
• K111532 — MONTBLANC SURGICAL CONTRA-ANGLE AND STRAIGHT HANDPIECE2011-10-07
• K102241 — ANTHOGYR IMPLANTEO IMPLANTOLOGY AND DENTAL SURGICAL MOTOR UNIT2011-03-23
• K101913 — ANTHOFIT OI, ANTHOFIT HE, OSSFIT AND AXIOM2011-03-11

Death

28

Injury

3,367,041

Malfunction

19,958

Other

13

Total

3,387,040

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-2754-2016 — Axiom 2.8 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 restorations or partial dentures. There are different diameters and different lengths for each diameter.Class II·Terminated·Anthogyr·20160620

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K141450.