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FDA 510(k)

CLEAR IMAGE ALIGNER

K-Number: K071970 · 2007-09-25

ApplicantSpecialty Appliance Works, Inc.
Decision Date2007-09-25
Product CodeNXC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CLEAR IMAGE ALIGNER is the device name listed in this FDA 510(k) record. The listed applicant is Specialty Appliance Works, Inc.. It received FDA 510(k) clearance on 2007-09-25 under 510(k) number K071970. 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 CLEAR IMAGE ALIGNER?

CLEAR IMAGE ALIGNER is a medical device that received FDA 510(k) clearance on 2007-09-25. The listed applicant is Specialty Appliance Works, Inc.. The 510(k) number is K071970.

When did CLEAR IMAGE ALIGNER receive FDA 510(k) clearance?

CLEAR IMAGE ALIGNER received FDA 510(k) clearance on 2007-09-25, under 510(k) number K071970.

Who is the listed applicant for CLEAR IMAGE ALIGNER?

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

What is the FDA product code for CLEAR IMAGE ALIGNER?

The FDA product code for CLEAR IMAGE 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 Specialty Appliance Works, 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.

K183643Clear Image AlignersK083209ACRYLIC HERBST SPLINT APPLIANCE

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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