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510(k) K954637

AMERICAN DENTAL PRODUCTS TISSUE CONDITIONER & TEMPORARY RELINER by American Dental Products, Inc. — Product Code EBI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 28, 1995
Date Received
October 6, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Resin, Denture, Relining, Repairing, Rebasing
Device Class
Class II
Regulation Number
872.3760
Review Panel
DE
Submission Type

Other clearances by American Dental Products, Inc.

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  • 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)
  • 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)
  • K954405 — AMERICAN DENTAL PRODDUCTS LIGHT ACTIVATED COMPOSITE RESIN CORE PASTE WITH FLUORI (October 30, 1995)

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