Cleared Traditional

K252760 - Carriere Motion Pro Clear Bite Corrector

K252760 is an FDA 510(k) clearance for Carriere Motion Pro Clear Bite Corrector, manufactured by Ortho Organizers, Inc.. The device is a Class 2 Dental device with product code DYW cleared through the Traditional 510(k) pathway after a 90-day FDA review.

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

K252760 is an FDA 510(k) clearance for the Carriere® Motion Pro® Clear Bite Corrector. Classified as Bracket, Plastic, Orthodontic (product code DYW), Class II - Special Controls.

Submitted by Ortho Organizers, Inc. (Carlsbad, US). The FDA issued a Cleared decision on November 27, 2025 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.5470 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Ortho Organizers, Inc. devices

FDA 510(k) Submission Details - K252760

510(k) Number K252760 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 127d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DYW Device Classification - Class 2, Special Controls

Product Code DYW Bracket, Plastic, Orthodontic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.5470
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - DYW Bracket, Plastic, Orthodontic

All 22
Devices cleared under the same product code (DYW) and FDA review panel - the closest regulatory comparables to K252760.
Composite Orthodontic Brackets and Buttons
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Braces on Demand Bracket
K201940 · Braces on Demand, Inc. · Dec 2020
Blue Sky Bio Computerized Orthodontic Bracket System
K182338 · Blue Sky Bio · Nov 2018
ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIES
K180718 · Tomy, Inc. · Oct 2018
INSIGNIA DIGICAST
K123118 · Ormco Corp. · Mar 2013
INSIGNIA WITH ITERO
K123416 · Ormco Corp. · Mar 2013