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510(k) K123416

INSIGNIA WITH ITERO by Ormco Corp. — Product Code DYW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 13, 2013
Date Received
November 6, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bracket, Plastic, Orthodontic
Device Class
Class II
Regulation Number
872.5470
Review Panel
DE
Submission Type

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