Cleared Traditional

K071352 - CERADRILL
(FDA 510(k) Clearance)

K071352 · Gebr. Brasseler GmbH & Co. KG · Dental device

Jun 2007

Decision

45d

Days

Class 1

Risk

K071352 is an FDA 510(k) clearance for the CERADRILL. This device is classified as a Bur, Dental (Class I - General Controls, product code EJL).

Submitted by Gebr. Brasseler GmbH & Co. KG (Lemgo, DE). The FDA issued a Cleared decision on June 29, 2007, 45 days after receiving the submission on May 15, 2007.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3240.

Submission Details

510(k) Number	K071352 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	May 15, 2007
Decision Date	June 29, 2007
Days to Decision	45 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF