Perfit ZR ST Dental Zirconia blank, Perfit ZR UT Dental Zirconia blank— 510(k) K203499

Name: FDA 510(k) clearance K203499
Creator: U.S. Food and Drug Administration
Published: 2021-04-05

Substantially Equivalent

Vatech Acucera, Inc.

FDA 510(k) clearance K203499 for Perfit ZR ST Dental Zirconia blank, Perfit ZR UT Dental Zirconia blank, Substantially Equivalent on 2021-04-05. Applicant: Vatech Acucera, Inc.. Device class: 2.

Clearance details

Applicant: Vatech Acucera, Inc.
Product code: Code EIH
Device class: Class 2
Regulation: 21 CFR 872.6660
Advisory panel: Dental
Date received: 2020-11-27
Decision date: 2021-04-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yongin-Si, KR

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.