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510(k) K081291

PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM EXTENSION by Dentsply Interntional — Product Code DYH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 22, 2008
Date Received
May 7, 2008
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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