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510(k) K954876

AMERICAN DENTAL PRODUCTS ROOT CANAL SEALER, WACH'S FORMULA by American Dental Products, Inc. — Product Code EMA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 15, 1995
Date Received
October 24, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cement, Dental
Device Class
Class II
Regulation Number
872.3275
Review Panel
DE
Submission Type

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  • 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)
  • K954408 — AMERICAN DENTAL PRODUCTS LIGHT ACTIVATED COMPOSITE RESIN CORE BUILDUP BLUE PASTE (October 30, 1995)
  • K954406 — AMERICAN DENTAL PRODUCTS COMPOSITE RESIN CORE PASTE WITH FLUORIDE (October 30, 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)

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