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FDA 510(k)

Carriere® Motion Pro® Clear Bite Corrector

K-Number: K252760 · 2025-11-27

Decision Date2025-11-27
Product CodeDYW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Carriere® Motion Pro® Clear Bite Corrector is the device name listed in this FDA 510(k) record. The listed applicant is Ortho Organizers, Inc.. It received FDA 510(k) clearance on 2025-11-27 under 510(k) number K252760. The device is classified under product code DYW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Carriere® Motion Pro® Clear Bite Corrector?

Carriere® Motion Pro® Clear Bite Corrector is a medical device that received FDA 510(k) clearance on 2025-11-27. The listed applicant is Ortho Organizers, Inc.. The 510(k) number is K252760.

When did Carriere® Motion Pro® Clear Bite Corrector receive FDA 510(k) clearance?

Carriere® Motion Pro® Clear Bite Corrector received FDA 510(k) clearance on 2025-11-27, under 510(k) number K252760.

Who is the listed applicant for Carriere® Motion Pro® Clear Bite Corrector?

The FDA 510(k) record lists Ortho Organizers, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Carriere® Motion Pro® Clear Bite Corrector?

The FDA product code for Carriere® Motion Pro® Clear Bite Corrector is DYW.

Other records listing Ortho Organizers, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Related Devices (Code: DYW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.