Cleared Abbreviated

K101913 - ANTHOFIT OI, ANTHOFIT HE, OSSFIT AND AXIOM (FDA 510(k) Clearance)

Class II Dental device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K101913 · Anthogyr Sas · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2011
Decision
246d
Days
Class 2
Risk

K101913 is an FDA 510(k) clearance for the ANTHOFIT OI, ANTHOFIT HE, OSSFIT AND AXIOM. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Anthogyr Sas (Sallanches, FR). The FDA issued a Cleared decision on March 11, 2011 after a review of 246 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3640 - the FDA dental device regulatory framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Anthogyr Sas devices

Submission Details

510(k) Number K101913 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 2010
Decision Date March 11, 2011
Days to Decision 246 days
Submission Type Abbreviated
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
119d slower than avg
Panel avg: 127d · This submission: 246d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code DZE Implant, Endosseous, Root-form
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3640
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - DZE Implant, Endosseous, Root-form

All 1541
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K101913.
Adin Long Dental Implant System
K252031 · Adin Dental Implant Systems , Ltd. · Mar 2026
ZENEX Implant System_Short (R-System)
K253334 · Izenimplant Co., Ltd. · Mar 2026
Straumann® BLC Implants - Indication Widening
K252168 · Institut Straumann AG · Mar 2026
Dentis SQ-SL AXEL Fixture
K253493 · Dentis Co., Ltd. · Mar 2026
Nobel Biocare S Series Implants
K252197 · Nobel Biocare AB · Feb 2026
BIORES Dental Implant System
K252286 · Chengdu Besmile Medical Technology Co., Ltd. · Feb 2026