Cleared Traditional

VITA Ambria

K193436 · Vita Zahnfabrik GmbH H Rauter & CO · Dental

May 2020

Decision

155d

Days

Class 2

Risk

About This 510(k) Submission

K193436 is an FDA 510(k) clearance for the VITA Ambria, 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 May 14, 2020, 155 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	K193436 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 11, 2019
Decision Date	May 14, 2020
Days to Decision	155 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF