Cleared Special

VITA VMK MASTER

K093446 · Vita Zahnfabrik H. Rauter GmbH & Co. Kg. · Dental

Dec 2009

Decision

28d

Days

Class 2

Risk

About This 510(k) Submission

K093446 is an FDA 510(k) clearance for the VITA VMK MASTER, a Powder, Porcelain (Class II — Special Controls, product code EIH), submitted by Vita Zahnfabrik H. Rauter GmbH & Co. Kg. (Brea, US). The FDA issued a Cleared decision on December 3, 2009, 28 days after receiving the submission on November 5, 2009. This device falls under the Dental review panel. Regulated under 21 CFR 872.6660.

Submission Details

510(k) Number	K093446 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 05, 2009
Decision Date	December 03, 2009
Days to Decision	28 days
Submission Type	Special
Review Panel	Dental (DE)
Summary	Statement