Cleared Abbreviated

K141450 - AXIOM 2.8

K141450 is an FDA 510(k) clearance for AXIOM 2.8, manufactured by Anthogyr Sas. The device is a Class 2 Dental device with product code DZE cleared through the Abbreviated 510(k) pathway after a 107-day FDA review.

K141450 · Anthogyr Sas · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2014
Decision
107d
Days
Class 2
Risk

K141450 is an FDA 510(k) clearance for the AXIOM 2.8. 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 September 17, 2014 after a review of 107 days - within the typical 510(k) review window.

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.

FDA 510(k) Submission Details - K141450

510(k) Number K141450 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 2014
Decision Date September 17, 2014
Days to Decision 107 days
Submission Type Abbreviated
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 128d · This submission: 107d
Pathway characteristics
Standards-based clearance path.

DZE Device Classification - Class 2, Special Controls

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 1424
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