Cleared Traditional

Carriere? Motion Pro? Clear Bite Corrector

K252760 · Ortho Organizers, Inc. · Dental
Nov 2025
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K252760 is an FDA 510(k) clearance for the Carriere? Motion Pro? Clear Bite Corrector, a Bracket, Plastic, Orthodontic (Class II — Special Controls, product code DYW), submitted by Ortho Organizers, Inc. (Carlsbad, US). The FDA issued a Cleared decision on November 27, 2025, 90 days after receiving the submission on August 29, 2025. This device falls under the Dental review panel. Regulated under 21 CFR 872.5470.

Submission Details

510(k) Number K252760 FDA.gov
FDA Decision Cleared SESE
Date Received August 29, 2025
Decision Date November 27, 2025
Days to Decision 90 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code DYW — Bracket, Plastic, Orthodontic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.5470

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