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510(k) K231884

TRIOCLEAR System by Modern Dental Laboratory (Dg) Co., Ltd. — Product Code NXC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 1, 2023
Date Received
June 27, 2023
Clearance Type
Special
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.

Other clearances by Modern Dental Laboratory (Dg) Co., Ltd.

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