Cleared Special

MONTBLANC IMPLANTOLOGY AND OMNIPRATIQUE CONTRA-ANGLES

K090676 · Anthogyr · Dental
May 2009
Decision
70d
Days
Class 1
Risk

About This 510(k) Submission

K090676 is an FDA 510(k) clearance for the MONTBLANC IMPLANTOLOGY AND OMNIPRATIQUE CONTRA-ANGLES, a Handpiece, Belt And/or Gear Driven, Dental (Class I — General Controls, product code EFA), submitted by Anthogyr (Sallanches, FR). The FDA issued a Cleared decision on May 22, 2009, 70 days after receiving the submission on March 13, 2009. This device falls under the Dental review panel. Regulated under 21 CFR 872.4200.

Submission Details

510(k) Number K090676 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code EFA — Handpiece, Belt And/or Gear Driven, Dental
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.4200