Cleared Traditional

IMPLANTOLOGY CONTRA ANGLES, ENDODONTIC CONTRA ANGLES, GENERAL DENTISTRY CONTRA ANGLES

K040674 · Anthogyr · Dental

Jun 2004

Decision

107d

Days

Class 1

Risk

About This 510(k) Submission

K040674 is an FDA 510(k) clearance for the IMPLANTOLOGY CONTRA ANGLES, ENDODONTIC CONTRA ANGLES, GENERAL DENTISTRY 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 June 30, 2004, 107 days after receiving the submission on March 15, 2004. This device falls under the Dental review panel. Regulated under 21 CFR 872.4200.

Submission Details

510(k) Number	K040674 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 15, 2004
Decision Date	June 30, 2004
Days to Decision	107 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF