510(k) K252760

Carriere® Motion Pro® Clear Bite Corrector by Ortho Organizers, Inc. — Product Code DYW

K252760 is an FDA 510(k) premarket notification submitted by Ortho Organizers, Inc. for the device "Carriere® Motion Pro® Clear Bite Corrector". The FDA issued a decision of Substantially Equivalent on November 27, 2025. The device falls under product code DYW (Bracket, Plastic, Orthodontic), a Class II device regulated under 21 CFR 872.5470. Ortho Organizers, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 27, 2025
Date Received
August 29, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bracket, Plastic, Orthodontic
Device Class
Class II
Regulation Number
872.5470
Review Panel
DE
Submission Type