BeautiBond Xtreme— 510(k) K213965

Substantially Equivalent

Shofu Dental Corporation

FDA 510(k) clearance K213965 for BeautiBond Xtreme, Substantially Equivalent on 2022-03-18. Applicant: Shofu Dental Corporation. Device class: 2.

Clearance details

Applicant: Shofu Dental Corporation
Product code: Code KLE
Device class: Class 2
Regulation: 21 CFR 872.3200
Advisory panel: Dental
Date received: 2021-12-20
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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