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510(k) K181747

Orthodontic Appliance by Shandong Huge Dental Material Corporation — Product Code NXC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 18, 2019
Date Received
July 2, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

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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