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510(k) K093221

PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM EXTENSION II by Dentsply Intl., Inc. — Product Code DYH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 30, 2009
Date Received
October 13, 2009
Clearance Type
Special
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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