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510(k) K210613

HIT Clear Aligner by Cdb Corporation — Product Code NXC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 4, 2021
Date Received
March 1, 2021
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.

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  • K091702 — CDB FLIP-SIDE-CLIP BRACKET (August 7, 2009)
  • K080906 — CDB CLIP (October 17, 2008)

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