Cleared Traditional

BECE CAD ZIRKON HT+

K132102 · Bego Bremer Goldschlaegerei Wilh. Herbst GmbH & CO · Dental

Nov 2013

Decision

127d

Days

Class 2

Risk

About This 510(k) Submission

K132102 is an FDA 510(k) clearance for the BECE CAD ZIRKON HT+, 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 November 12, 2013, 127 days after receiving the submission on July 8, 2013. This device falls under the Dental review panel. Regulated under 21 CFR 872.6660.

Submission Details

510(k) Number	K132102 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 08, 2013
Decision Date	November 12, 2013
Days to Decision	127 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF