510(k) K252785— TopCEM Vigor SA Self-Adhesive Resin Cement

Substantially Equivalent

Rizhao Huge Biomaterials Company, Ltd.

Clearance details

Applicant: Rizhao Huge Biomaterials Company, Ltd.
Product code: Code EMA
Advisory panel: Dental
Date received: 2025-09-02
Decision date: 2025-12-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rizhao, CN

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.