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510(k) K935714

CRYSTALLINE L3 MULTI-USE HYBRID COMPOSITE by Confi-Dental Products Co. — Product Code DYH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 21, 1994
Date Received
November 30, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Adhesive, Bracket And Tooth Conditioner, Resin
Device Class
Class II
Regulation Number
872.3750
Review Panel
DE
Submission Type

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  • 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)
  • K933199 — CRYSTALLINE 'FLUORITE' CORE BUILD-UP MATERIAL (January 6, 1994)

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