Cleared Traditional

BECE PRESS

K090434 · Bego Bremer Goldschlaegerei Wilh. Herbst GmbH & CO · Dental

Jul 2009

Decision

137d

Days

Class 2

Risk

About This 510(k) Submission

K090434 is an FDA 510(k) clearance for the BECE PRESS, a Powder, Porcelain (Class II — Special Controls, product code EIH), submitted by Bego Bremer Goldschlaegerei Wilh. Herbst GmbH & CO (Bremen, DE). The FDA issued a Cleared decision on July 6, 2009, 137 days after receiving the submission on February 19, 2009. This device falls under the Dental review panel. Regulated under 21 CFR 872.6660.

Submission Details

510(k) Number	K090434 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 19, 2009
Decision Date	July 06, 2009
Days to Decision	137 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF