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FDA 510(k)

RED, WHITE & BLUE

K-Number: K040874 · 2004-06-18

ApplicantAllesee Orthodontic Appliances
Decision Date2004-06-18
Product CodeNXC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

RED, WHITE & BLUE is the device name listed in this FDA 510(k) record. The listed applicant is Allesee Orthodontic Appliances. It received FDA 510(k) clearance on 2004-06-18 under 510(k) number K040874. The device is classified under product code NXC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RED, WHITE & BLUE?

RED, WHITE & BLUE is a medical device that received FDA 510(k) clearance on 2004-06-18. The listed applicant is Allesee Orthodontic Appliances. The 510(k) number is K040874.

When did RED, WHITE & BLUE receive FDA 510(k) clearance?

RED, WHITE & BLUE received FDA 510(k) clearance on 2004-06-18, under 510(k) number K040874.

Who is the listed applicant for RED, WHITE & BLUE?

The FDA 510(k) record lists Allesee Orthodontic Appliances as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RED, WHITE & BLUE?

The FDA product code for RED, WHITE & BLUE is NXC.

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Other records listing Allesee Orthodontic Appliances 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.

K093821FS ALIGNER

Related Devices (Code: NXC)

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.

K260527FACE4D AlignerAvinent Implant System S.L.U.K260788Smylio AlignersSmylio, Inc.K260722SureSmile Aligner (ASSY500020)Dentsply Sirona, Inc.K253282ZSmile SystemDror Orthodesign , Ltd.K251454Clear Aligner (SCF-3348)Beame Medical Technology (Shenzhen) LimitedK250739Primeprint Direct AlignerDreve Dentamid GmbH

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.

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