Cleared Traditional

K012505 - SOPRO595 INTRA ORAL CAMERA (FDA 510(k) Clearance)

K012505 · Sopro · Dental device

Oct 2001

Decision

63d

Days

Class 1

Risk

K012505 is an FDA 510(k) clearance for the SOPRO595 INTRA ORAL CAMERA. This device is classified as a Unit, Operative Dental (Class I - General Controls, product code EIA).

Submitted by Sopro (Marseille, FR). The FDA issued a Cleared decision on October 5, 2001, 63 days after receiving the submission on August 3, 2001.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6640.

Submission Details

510(k) Number	K012505 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 03, 2001
Decision Date	October 05, 2001
Days to Decision	63 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF