FDA · official record K211854Substantially Equivalent

VITA Akzent LC

Name: VITA Akzent LC — FDA K211854
Creator: Vita Zahnfabrik GmbH H Rauter & CO
Keywords: VITA Akzent LC, VITA Akzent LC, K211854, EBD, FDA

United StatesEBDVita Zahnfabrik GmbH H Rauter & CO

Verified

Official record identity

FDA application number: K211854
Decision date: November 22, 2021
Published decision: Substantially Equivalent

Classification

Product code: EBD

Published parties

Applicant: Vita Zahnfabrik GmbH H Rauter & CO

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2021-06-16
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.3310

About this record

This record preserves an application published in the FDA 510(k) bulk export, including the DEN entries FDA includes in that export. Historical decisions do not establish current marketing status. Product-code harmonization is separate from the original application; joined establishment identifiers are not assigned to the applicant. The complete official export is checked daily and raw evidence is retained.