Cleared Traditional

VITA Akzent LC

K211854 · Vita Zahnfabrik GmbH H Rauter & CO · Dental

Nov 2021

Decision

159d

Days

Class 2

Risk

About This 510(k) Submission

K211854 is an FDA 510(k) clearance for the VITA Akzent LC, a Coating, Filling Material, Resin (Class II — Special Controls, product code EBD), submitted by Vita Zahnfabrik GmbH H Rauter & CO (Bad Sackingen, DE). The FDA issued a Cleared decision on November 22, 2021, 159 days after receiving the submission on June 16, 2021. This device falls under the Dental review panel. Regulated under 21 CFR 872.3310.

Submission Details

510(k) Number	K211854 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 16, 2021
Decision Date	November 22, 2021
Days to Decision	159 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF