Cleared Special

MONTBLANC IMPLANTOLOGY CONTRA ANGLE CONTROL (K070084) - FDA 510(k) Clearance

Class I Dental device.

K070084 · Est. Anthogyr · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2007
Decision
58d
Days
Class 1
Risk

K070084 is an FDA 510(k) clearance for the MONTBLANC IMPLANTOLOGY CONTRA ANGLE CONTROL. Classified as Handpiece, Belt And/or Gear Driven, Dental (product code EFA), Class I - General Controls.

Submitted by Est. Anthogyr (Sallanches, FR). The FDA issued a Cleared decision on March 8, 2007 after a review of 58 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 Est. Anthogyr devices

Submission Details

510(k) Number K070084 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 09, 2007
Decision Date March 08, 2007
Days to Decision 58 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
69d faster than avg
Panel avg: 127d · This submission: 58d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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.