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510(k) K233082

TopCEM Dual Cure Resin Cement by Rizhao Huge Biomaterials Company, Ltd. — Product Code EBF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 2023
Date Received
September 26, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Material, Tooth Shade, Resin
Device Class
Class II
Regulation Number
872.3690
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)
  • 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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