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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / November 2025 / K252760

510(k) cleared

Carriere® Motion Pro® Clear Bite Corrector

Ortho Organizers, Inc. · Nov 27, 2025 · K252760

FDA cleared the Carriere® Motion Pro® Clear Bite Corrector from Ortho Organizers, Inc. on Nov 27, 2025 under K252760, a traditional 510(k). The device falls under product code DYW, Bracket, Plastic, Orthodontic, regulated at 21 CFR 872.5470 as a Class 2 device. The review panel was Dental.

FDA logged the submission as received on Aug 29, 2025. The decision came 90 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Ortho Organizers, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252760?

K252760 is the FDA 510(k) for Carriere® Motion Pro® Clear Bite Corrector, submitted by Ortho Organizers, Inc.. FDA's decision date was Nov 27, 2025, under product code DYW (Bracket, Plastic, Orthodontic).

Who makes the Carriere® Motion Pro® Clear Bite Corrector?

Ortho Organizers, Inc., based in Carlsbad, CA, is the applicant of record for K252760.

How long did the K252760 review take?

FDA received the submission on Aug 29, 2025 and issued its decision on Nov 27, 2025, 90 days later.

← All decisions in November 2025