Perfit FS Dental Zirconia Fully Sintered Block— 510(k) K203590

Name: FDA 510(k) clearance K203590
Creator: U.S. Food and Drug Administration
Published: 2021-06-24

Substantially Equivalent

Vatech Acucera, Inc.

FDA 510(k) clearance K203590 for Perfit FS Dental Zirconia Fully Sintered Block, Substantially Equivalent on 2021-06-24. 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: 2020-12-08
Decision date: 2021-06-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yongin-Si, KR

Download summary PDF View on FDA.gov ↗

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