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510(k) K252785

TopCEM Vigor SA Self-Adhesive Resin Cement by Rizhao Huge Biomaterials Company, Ltd. — Product Code EMA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 12, 2025
Date Received
September 2, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cement, Dental
Device Class
Class II
Regulation Number
872.3275
Review Panel
DE
Submission Type

Other clearances by Rizhao Huge Biomaterials Company, Ltd.

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  • K242749 — TopCEM Ceramic Primer Ceramic Coupling Agent (November 8, 2024)
  • K241204 — TopCEM-Veneer Light Cure Veneer Cement (June 28, 2024)
  • K233082 — TopCEM Dual Cure Resin Cement (December 22, 2023)
  • K230455 — Enamel Coating Resin (July 25, 2023)
  • K221510 — TrusFIL-Flow Flowable Composite Restorative (October 12, 2022)
  • K221450 — Phosphoric Acid Etching Gel (September 12, 2022)
  • K202063 — TrusFIL Universal Composite Restorative (October 6, 2021)

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