SHOFU RESIN GLAZE— 510(k) K163568

Substantially Equivalent

Shofu Dental Corporation

FDA 510(k) clearance K163568 for SHOFU RESIN GLAZE, Substantially Equivalent on 2017-08-16. Applicant: Shofu Dental Corporation. Device class: 2.

Clearance details

Applicant: Shofu Dental Corporation
Product code: Code EBD
Device class: Class 2
Regulation: 21 CFR 872.3310
Advisory panel: Dental
Date received: 2016-12-19
Decision date: 2017-08-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Marcos, CA, US

Download summary PDF View on FDA.gov ↗

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