Cleared Traditional

K033597 - ATR 5000, LC 5000, IMPLANT SYSTEM (FDA 510(k) Clearance)

K033597 · Advanced Technology Research (A.T.R.) S.R.L. · Dental device

Nov 2003

Decision

11d

Days

Class 1

Risk

K033597 is an FDA 510(k) clearance for the ATR 5000, LC 5000, IMPLANT SYSTEM. This device is classified as a Handpiece, Direct Drive, Ac-powered (Class I - General Controls, product code EKX).

Submitted by Advanced Technology Research (A.T.R.) S.R.L. (Pistoia, IT). The FDA issued a Cleared decision on November 25, 2003, 11 days after receiving the submission on November 14, 2003.

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

Submission Details

510(k) Number	K033597 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 14, 2003
Decision Date	November 25, 2003
Days to Decision	11 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF