Home / 510(k) Clearances / K242572

510(k) K242572

TopCEM-Try in Veneer Try-in Gel by Rizhao Huge Biomaterials Company, Ltd. — Product Code EBF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 20, 2024
Date Received
August 29, 2024
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.

  • K252785 — TopCEM Vigor SA Self-Adhesive Resin Cement (December 12, 2025)
  • K251271 — TempFIT Temporary Crown and Bridge Resin (June 23, 2025)
  • K242530 — HF-Etchant Hydrofluoric Acid Etching Gel (December 20, 2024)
  • 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)

Other clearances for product code EBF

  • K260783 — Venus Diamond; Venus Diamond Flow; Venus Pearl; Venus Bulk Flow One (March 11, 2026)
  • K254245 — ZAFIRA® (March 3, 2026)
  • K260170 — LumiCera (January 21, 2026)
  • K252465 — Any-Core (December 5, 2025)
  • K253513 — MultiMatch Flow Chameleon AntiMicrobial Composite (November 7, 2025)
  • K253236 — G-BLOCK (September 29, 2025)
  • K253053 — Dura-Crown (CB21-A1/CB21-A2/CB21-A3/CB21-B1) (September 23, 2025)
  • K251946 — G aenial Universal Injectable II (August 29, 2025)
  • K251283 — Once-Fil Flow (June 6, 2025)
  • K250317 — EsFlow PLUS (May 30, 2025)