Cleared Special

K090676 - MONTBLANC IMPLANTOLOGY AND OMNIPRATIQUE...

K090676 is an FDA 510(k) clearance for MONTBLANC IMPLANTOLOGY AND OMNIPRATIQUE..., manufactured by Anthogyr. The device is a Class 1 Dental device with product code EFA cleared through the Special 510(k) pathway after a 70-day FDA review.

K090676 · Anthogyr · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2009
Decision
70d
Days
Class 1
Risk

K090676 is an FDA 510(k) clearance for the MONTBLANC IMPLANTOLOGY AND OMNIPRATIQUE CONTRA-ANGLES. Classified as Handpiece, Belt And/or Gear Driven, Dental (product code EFA), Class I - General Controls.

Submitted by Anthogyr (Sallanches, FR). The FDA issued a Cleared decision on May 22, 2009 after a review of 70 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4200 - the FDA dental device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Anthogyr devices

FDA 510(k) Submission Details - K090676

510(k) Number K090676 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 2009
Decision Date May 22, 2009
Days to Decision 70 days
Submission Type Special
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
57d faster than avg
Panel avg: 127d · This submission: 70d
Pathway characteristics
Modification to existing cleared device.

EFA Device Classification - Class 1, General Controls

Product Code EFA Handpiece, Belt And/or Gear Driven, Dental
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4200
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - EFA Handpiece, Belt And/or Gear Driven, Dental

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