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510(k) K954373

AMERICAN DENTAL PRODUCTS PASTE-PRIMER ADHESIVE ORTHODONTIC BONDING SYSTEM W/FLUORIDE by American Dental Products, Inc. — Product Code DYH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 19, 1995
Date Received
September 19, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Adhesive, Bracket And Tooth Conditioner, Resin
Device Class
Class II
Regulation Number
872.3750
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)

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