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510(k) K022973

ADHESIVE 14 by Ab Ardent — Product Code KLE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 22, 2002
Date Received
September 6, 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 Ab Ardent

  • K131753 — MERIDIAN (November 14, 2013)
  • K040465 — LATIT FLOW (July 20, 2004)
  • K022971 — MICROHYBRID 11 (November 25, 2002)
  • K022972 — MICROFILL 13 (November 22, 2002)
  • K022975 — ETCHING 15 (November 22, 2002)
  • K022974 — MICROHYBRID 12 (November 22, 2002)
  • K020452 — HIGH SILVER CONVENTIONAL (May 7, 2002)
  • K011801 — FUTURA TOPCAP NON GAMMA-2 (August 16, 2001)
  • K991974 — FUTURA GLASS IONOMER SILVER REINFORCED (September 17, 1999)
  • K982458 — VIVALLOY HR (August 24, 1998)

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  • 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)