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510(k) K030743

ETCHANT 40% by Confi-Dental Products Co. — Product Code KLE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 9, 2003
Date Received
March 10, 2003
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

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  • K952930 — DENTRAY II PLUS TRAY ADHESIVE (September 8, 1995)
  • K946307 — CYRSTALLINE L3 MULTI-USE HYBRID COMPOSITE (January 26, 1995)
  • K940546 — GRANITEC IONOMER RESIN CEMENT (April 29, 1994)
  • K936070 — TREND SET 2 PLUS (February 4, 1994)
  • K935714 — CRYSTALLINE L3 MULTI-USE HYBRID COMPOSITE (January 21, 1994)
  • K933199 — CRYSTALLINE 'FLUORITE' CORE BUILD-UP MATERIAL (January 6, 1994)

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