Cleared Traditional

VITA LUMEX AC

K193434 · Vita Zahnfabrik GmbH H Rauter & CO · Dental

Jul 2020

Decision

223d

Days

Class 2

Risk

About This 510(k) Submission

K193434 is an FDA 510(k) clearance for the VITA LUMEX AC, a Powder, Porcelain (Class II — Special Controls, product code EIH), submitted by Vita Zahnfabrik GmbH H Rauter & CO (Bad Sackingen, DE). The FDA issued a Cleared decision on July 21, 2020, 223 days after receiving the submission on December 11, 2019. This device falls under the Dental review panel. Regulated under 21 CFR 872.6660.

Submission Details

510(k) Number	K193434 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 11, 2019
Decision Date	July 21, 2020
Days to Decision	223 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF