TopCEM Ceramic Primer Ceramic Coupling Agent— 510(k) K242749

Substantially Equivalent

Rizhao Huge Biomaterials Company, Ltd.

FDA 510(k) clearance K242749 for TopCEM Ceramic Primer Ceramic Coupling Agent, Substantially Equivalent on 2024-11-08. Applicant: Rizhao Huge Biomaterials Company, Ltd..

Clearance details

Applicant: Rizhao Huge Biomaterials Company, Ltd.
Product code: Code KLE
Advisory panel: Dental
Date received: 2024-09-12
Decision date: 2024-11-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rizhao, CN

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