Vintage Prime Press— 510(k) K212939

Substantially Equivalent

Shofu Dental Corporation

FDA 510(k) clearance K212939 for Vintage Prime Press, Substantially Equivalent on 2022-03-18. Applicant: Shofu Dental Corporation. Device class: 2.

Clearance details

Applicant: Shofu Dental Corporation
Product code: Code EIH
Device class: Class 2
Regulation: 21 CFR 872.6660
Advisory panel: Dental
Date received: 2021-09-15
Decision date: 2022-03-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Marcos, CA, US

Download summary PDF View on FDA.gov ↗

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