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FDA 510(k)

CLEARPATH ALIGNER

K-Number: K123514 · 2013-11-01

ApplicantQserve America, Inc.
Decision Date2013-11-01
Product CodeNXC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CLEARPATH ALIGNER is the device name listed in this FDA 510(k) record. The listed applicant is Qserve America, Inc.. It received FDA 510(k) clearance on 2013-11-01 under 510(k) number K123514. 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 CLEARPATH ALIGNER?

CLEARPATH ALIGNER is a medical device that received FDA 510(k) clearance on 2013-11-01. The listed applicant is Qserve America, Inc.. The 510(k) number is K123514.

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

CLEARPATH ALIGNER received FDA 510(k) clearance on 2013-11-01, under 510(k) number K123514.

Who is the listed applicant for CLEARPATH ALIGNER?

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

What is the FDA product code for CLEARPATH ALIGNER?

The FDA product code for CLEARPATH 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 Qserve America, 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.

K110246MEDISIZE RED AND MEDISIZE 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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