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510(k) K955328

CONFI-BOND by Confi-Dental Products Co. — Product Code KLE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 28, 1996
Date Received
November 20, 1995
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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  • K940546 — GRANITEC IONOMER RESIN CEMENT (April 29, 1994)
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  • K935714 — CRYSTALLINE L3 MULTI-USE HYBRID COMPOSITE (January 21, 1994)
  • K933199 — CRYSTALLINE 'FLUORITE' CORE BUILD-UP MATERIAL (January 6, 1994)

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