FDA · official record K203351Substantially Equivalent

Perfit ZR HT Dental Zirconia blank

Name: Perfit ZR HT Dental Zirconia blank — FDA K203351
Creator: Vatech Acucera, Inc.
Keywords: Perfit ZR HT Dental Zirconia blank, Perfit ZR HT Dental Zirconia blank, K203351, EIH, FDA

United StatesEIHVatech Acucera, Inc.

Verified

Official record identity

FDA application number: K203351
Decision date: March 08, 2021
Published decision: Substantially Equivalent

Classification

Product code: EIH

Published parties

Applicant: Vatech Acucera, Inc.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2020-11-13
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.6660

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.