ZIRCONOMER P— 510(k) K252165

Substantially Equivalent

Shofu Dental Corporation

FDA 510(k) clearance K252165 for ZIRCONOMER P, Substantially Equivalent on 2025-10-28. Applicant: Shofu Dental Corporation.

Clearance details

Applicant: Shofu Dental Corporation
Product code: Code EMA
Advisory panel: Dental
Date received: 2025-07-10
Decision date: 2025-10-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Marcos, CA, US

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