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510(k) K150830

CompleClear Plastic Orthodontic Bracket and Wire Appliance by Oracrew — Product Code DYW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 26, 2016
Date Received
March 30, 2015
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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