Cleared Abbreviated

K161177 - Axiom PX (FDA 510(k) Clearance)

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

K161177 · Anthogyr Sas · Dental device
Download Printable Device Report (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.

View all Anthogyr Sas devices

Submission Details

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
Regulatory Context
Review time vs. panel average
288d slower than avg
Panel avg: 127d · This submission: 415d
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
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