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FDA 510(k)

FS ALIGNER

K-Number: K093821 · 2010-08-27

ApplicantAllesee Orthodontic Appliances
Decision Date2010-08-27
Product CodeNXC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

FS ALIGNER 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 2010-08-27 under 510(k) number K093821. 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 FS ALIGNER?

FS ALIGNER is a medical device that received FDA 510(k) clearance on 2010-08-27. The listed applicant is Allesee Orthodontic Appliances. The 510(k) number is K093821.

When did FS ALIGNER receive FDA 510(k) clearance?

FS ALIGNER received FDA 510(k) clearance on 2010-08-27, under 510(k) number K093821.

Who is the listed applicant for FS ALIGNER?

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 FS ALIGNER?

The FDA product code for FS ALIGNER is NXC.

Related Clinical Trials

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.

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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.

K040874RED, WHITE & BLUE

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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