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510(k) K230465

Hi-Bond Universal by Mediclus Co., Ltd. — Product Code KLE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 22, 2023
Date Received
February 21, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Agent, Tooth Bonding, Resin
Device Class
Class II
Regulation Number
872.3200
Review Panel
DE
Submission Type

Other clearances by Mediclus Co., Ltd.

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  • K252465 — Any-Core (December 5, 2025)
  • K251884 — One-Fil Putty Injectable (August 22, 2025)
  • K251283 — Once-Fil Flow (June 6, 2025)
  • K250823 — Any-Com Flow (April 14, 2025)
  • K243353 — One-Fil Putty (March 14, 2025)
  • K242713 — Any-Com Bulk (February 7, 2025)
  • K241147 — Any-Com (September 26, 2024)
  • K232182 — One-Fil (January 26, 2024)

Other clearances for product code KLE

  • K252450 — Adhese 2 (March 5, 2026)
  • K260682 — Bond-PR™ Universal Adhesive (March 3, 2026)
  • K251587 — VITA VMLC Primer (February 23, 2026)
  • K252151 — els unibond (December 5, 2025)
  • K252469 — MAGNABOND SE; MAGNABOND UNIVERSAL; MAGNABOND UNIVERSAL DCA (November 6, 2025)
  • K251124 — G-Bond Universal (October 2, 2025)
  • K242530 — HF-Etchant Hydrofluoric Acid Etching Gel (December 20, 2024)
  • K242749 — TopCEM Ceramic Primer Ceramic Coupling Agent (November 8, 2024)
  • K242675 — FineEtch (FineEtch-10 1.2ml, FineEtch-10 5ml, FineEtch-37 1.2ml FineEtch-37 5ml, (November 1, 2024)
  • K240153 — Ceramic Etchant (HF-5 and HF-9) (October 2, 2024)