Cleared Abbreviated

K041279 - IMPLANTEO IMPLANTOLOGY MOTOR
(FDA 510(k) Clearance)

K041279 · Anthogyr · Dental

Sep 2004

Decision

133d

Days

Class 1

Risk

K041279 is an FDA 510(k) clearance for the IMPLANTEO IMPLANTOLOGY MOTOR. This device is classified as a Handpiece, Direct Drive, Ac-powered (Class I — General Controls, product code EKX).

Submitted by Anthogyr (Sallanches, FR). The FDA issued a Cleared decision on September 23, 2004, 133 days after receiving the submission on May 13, 2004.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4200.

Submission Details

510(k) Number	K041279 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 13, 2004
Decision Date	September 23, 2004
Days to Decision	133 days
Submission Type	Abbreviated
Review Panel	Dental (DE)
Summary	Summary PDF