Home / 510(k) Clearances / K954133

510(k) K954133

AMERICAN DENTAL PRODUCTS WETTING AGENT & DESENSITIZER by American Dental Products, Inc. — Product Code KLE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 30, 1995
Date Received
September 1, 1995
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 American Dental Products, Inc.

  • K093014 — AMERICAN DENTAL PRODUCTS SE BONDEASY (April 16, 2010)
  • K994368 — AMERICAN DENTAL PRODUCTS CARIES-DETECTOR PLUS (March 14, 2000)
  • K991099 — AMERICAN DENTAL PRODUCTS ETCH-DETECT (June 10, 1999)
  • K973185 — AMERICAN DENTAL PRODUCTS HB-35 DESENSITIZER WITH FLUORIDE (November 14, 1997)
  • K964133 — AMERICAN DENTAL PRODUCTS HG 35 DESENSITIZER WITH FLUORIDE (January 9, 1997)
  • K954637 — AMERICAN DENTAL PRODUCTS TISSUE CONDITIONER & TEMPORARY RELINER (December 28, 1995)
  • K954876 — AMERICAN DENTAL PRODUCTS ROOT CANAL SEALER, WACH'S FORMULA (November 15, 1995)
  • K954407 — AMERICAN DENTAL PRODUCTS WHITE COMPOSITE RESIN CORE PASTE WITH FLUORIDE (October 30, 1995)
  • K954701 — AMERICAN DENTAL PRODUCTS PIT & FISSUE SEALANT LIGHT CURING (October 30, 1995)
  • K954406 — AMERICAN DENTAL PRODUCTS COMPOSITE RESIN CORE PASTE WITH FLUORIDE (October 30, 1995)

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)