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510(k) K925359

RESILIENCE ORTHODONTIC BRACKET ADHES W/BOND RESINS by Confi-Dental Products Co. — Product Code DYH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 8, 1993
Date Received
October 22, 1992
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)
  • K935714 — CRYSTALLINE L3 MULTI-USE HYBRID COMPOSITE (January 21, 1994)

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