BEAUTIFIL II Enamel— 510(k) K151699

Substantially Equivalent

Shofu Dental Corporation

FDA 510(k) clearance K151699 for BEAUTIFIL II Enamel, Substantially Equivalent on 2015-12-10. Applicant: Shofu Dental Corporation. Device class: 2.

Clearance details

Applicant: Shofu Dental Corporation
Product code: Code EBF
Device class: Class 2
Regulation: 21 CFR 872.3690
Advisory panel: Dental
Date received: 2015-06-24
Decision date: 2015-12-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Marcos, CA, US

Download summary PDF View on FDA.gov ↗

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