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510(k) K230455

Enamel Coating Resin by Rizhao Huge Biomaterials Company, Ltd. — Product Code EBC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 25, 2023
Date Received
February 21, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sealant, Pit And Fissure, And Conditioner
Device Class
Class II
Regulation Number
872.3765
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)
  • 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 EBC

  • K243254 — Parkell Pit and Fissure Sealant (August 8, 2025)
  • K232498 — UltraSeal XT plus - Bioprotection by Nobio, UltraSeal XT hydro - Bioprotection b (August 18, 2023)
  • K190998 — BA Pit & Fissure Sealant (November 8, 2019)
  • K190339 — Helioseal F Plus (July 29, 2019)
  • K172169 — Pulpdent (Activa) Pit and Fissure Sealant with MCP (January 5, 2018)
  • K171330 — Nanova Sealant (September 8, 2017)
  • K162598 — HAPI Seal (May 23, 2017)
  • K161580 — Premier Sealant (October 18, 2016)
  • K141717 — PACSEAL PIT & FISSURE SEALANT (March 9, 2015)
  • K130485 — CONTROL SEAL (February 11, 2014)