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510(k) K163689

3M Clear Tray Aligner by 3M Unitek Corporation — Product Code NXC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 27, 2017
Date Received
December 28, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Aligner, Sequential
Device Class
Class II
Regulation Number
872.5470
Review Panel
DE
Submission Type

The device moves the teeth by continuous gentle force for treatment of minor tooth malocclusion.

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