SHOFU MZ Primer Plus— 510(k) K172106

Substantially Equivalent

Shofu Dental Corporation

FDA 510(k) clearance K172106 for SHOFU MZ Primer Plus, Substantially Equivalent on 2017-08-31. 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: 2017-07-12
Decision date: 2017-08-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Marcos, CA, US

Download summary PDF View on FDA.gov ↗

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