510(k) K241137

Clear Moves Aligner by Clear Moves Aligners — Product Code NXC

K241137 is an FDA 510(k) premarket notification submitted by Clear Moves Aligners for the device "Clear Moves Aligner". The FDA issued a decision of Substantially Equivalent on August 1, 2024. The device falls under product code NXC (Aligner, Sequential), a Class II device regulated under 21 CFR 872.5470.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 1, 2024
Date Received
April 24, 2024
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.