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510(k) K024356

CLEARFIL SILANE KIT by Kuraray Medical, Inc. — Product Code KLE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 26, 2003
Date Received
December 30, 2002
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 Kuraray Medical, Inc.

  • K120378 — PANAVIA SA CEMENT HANDMIX VALUE PACK (UNIVERSAL (A2), WHITE) PANAVIA SA CEMENT H (March 30, 2012)
  • K120379 — PANAVIA SA CEMENT AUTOMIX VALUE PACK (UNIVERSAL (A2), WHITE) PANAVIA SA CEMENT A (March 30, 2012)
  • K111975 — CLEARFIL TRI-S BOND PLUS SINGLE DOSE STANDARD / VALUE / INTRODUCTORY PACK (October 14, 2011)
  • K100328 — CLEARFIL MAJETY POSTERIOR (March 5, 2010)
  • K092281 — CLEARFIL MAJESTY POSTERIOR PLT (October 27, 2009)
  • K081583 — CLEARFIL SA CEMENT (July 28, 2008)
  • K071169 — CLEARFIL MAJESTY POSTERIOR PLT (June 20, 2007)
  • K070325 — CLEARFIL MAJESTY ESTHETIC PLT (March 21, 2007)
  • K062409 — K-ETCHANT GEL (November 8, 2006)
  • K061906 — CLEARFIL CERAMIC PRIMER (September 28, 2006)

Other clearances for product code KLE

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  • 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)