Cleared Abbreviated

K161177 - Axiom PX

K161177 is an FDA 510(k) clearance for Axiom PX, 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 415-day FDA review.

K161177 · Anthogyr Sas · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2017
Decision
415d
Days
Class 2
Risk

K161177 is an FDA 510(k) clearance for the Axiom PX. 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 June 15, 2017 after a review of 415 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Standards-verified equivalence. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

FDA 510(k) Submission Details - K161177

510(k) Number K161177 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 2016
Decision Date June 15, 2017
Days to Decision 415 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
287d slower than avg
Panel avg: 128d · This submission: 415d
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
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K161177.
Neodent Implant System - GM Line
K163194 · Jjgc Industria E Comercio DE Materiais Dentarios S.A. · Jul 2017
SpiralTech Dental Implant System
K170372 · Spiraltech Superior Dental Implants, Inc. · Jun 2017
Spiral Shape Dental Implant System
K162299 · Gp Implants · Jun 2017
Deep Conical (DC) Implants and Accessories
K163060 · Southern Implants (Pty), Ltd. · Jun 2017
MIS V3 Conical Connection Dental Implant System­
K163349 · Mis Implants Technologies , Ltd. · May 2017
Dental Implants OKTAGON Bone Level Tapered Design
K170287 · Hager& Meisinger GmbH · May 2017