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FDA 510(k)

Carriere Motion Clear Class II

K-Number: K160720 · 2016-11-28

ApplicantOrtho Organizers, Inc.
Decision Date2016-11-28
Product CodeDYW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Carriere Motion Clear Class II 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 2016-11-28 under 510(k) number K160720. 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 Clear Class II?

Carriere Motion Clear Class II is a medical device that received FDA 510(k) clearance on 2016-11-28. The listed applicant is Ortho Organizers, Inc.. The 510(k) number is K160720.

When did Carriere Motion Clear Class II receive FDA 510(k) clearance?

Carriere Motion Clear Class II received FDA 510(k) clearance on 2016-11-28, under 510(k) number K160720.

Who is the listed applicant for Carriere Motion Clear Class II?

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 Clear Class II?

The FDA product code for Carriere Motion Clear Class II 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.

K252760Carriere® Motion Pro® Clear Bite CorrectorK173440Carriere SLX 3D Clear

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.

K252760Carriere® Motion Pro® Clear Bite CorrectorOrtho Organizers, Inc.K251196Composite Orthodontic Brackets and ButtonsEc Certification Service GmbHK201940Braces on Demand BracketBraces on Demand, Inc.K182338Blue Sky Bio Computerized Orthodontic Bracket SystemBlue Sky BioK180718ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIESTomy, Inc.K150830CompleClear Plastic Orthodontic Bracket and Wire ApplianceOracrew

Official Source

View on FDA Database →

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

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