Cleared Special

ANTHOGYR IMPULSION IMPLANTOLOGY CONTRA-ANGLE

K093894 · Anthogyr · Dental
Mar 2010
Decision
75d
Days
Class 1
Risk

About This 510(k) Submission

K093894 is an FDA 510(k) clearance for the ANTHOGYR IMPULSION IMPLANTOLOGY CONTRA-ANGLE, 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 March 3, 2010, 75 days after receiving the submission on December 18, 2009. This device falls under the Dental review panel. Regulated under 21 CFR 872.4200.

Submission Details

510(k) Number K093894 FDA.gov
FDA Decision Cleared SESE
Date Received December 18, 2009
Decision Date March 03, 2010
Days to Decision 75 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