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510(k) K122522

DENTOETCH QUICKBOND BOND ACTIVATOR by Itena Clinical — Product Code KLE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 19, 2013
Date Received
August 20, 2012
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 Itena Clinical

  • K170207 — Obturys (July 31, 2017)
  • K162960 — TotalC-Ram (March 14, 2017)
  • K122551 — PROVITEMP (June 14, 2013)
  • K122521 — PREVENT SEAL (June 11, 2013)
  • K122549 — DENTO TEMP (April 26, 2013)
  • K121804 — PROVITEMP, DENTOTEMP, TOTALCEM, DENTOCEM (April 19, 2013)
  • K121769 — DENTOCORE / DENTOCORE BODY (March 5, 2013)

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)