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510(k) K954408

AMERICAN DENTAL PRODUCTS LIGHT ACTIVATED COMPOSITE RESIN CORE BUILDUP BLUE PASTEE by American Dental Products, Inc. — Product Code EBF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 30, 1995
Date Received
September 20, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Material, Tooth Shade, Resin
Device Class
Class II
Regulation Number
872.3690
Review Panel
DE
Submission Type

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

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