PRG BARRIER COAT— 510(k) K122908

Substantially Equivalent

Shofu Dental Corporation

FDA 510(k) clearance K122908 for PRG BARRIER COAT, Substantially Equivalent on 2013-04-26. Applicant: Shofu Dental Corporation. Device class: 2.

Clearance details

Applicant: Shofu Dental Corporation
Product code: Code LBH
Device class: Class 2
Regulation: 21 CFR 872.3260
Advisory panel: Dental
Date received: 2012-09-21
Decision date: 2013-04-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Marcos, CA, US

Download summary PDF View on FDA.gov ↗

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