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FDA 510(k)

MTM Clear Aligner

K-Number: K163155 · 2017-02-03

ApplicantDentsply Sirona
Decision Date2017-02-03
Product CodeNXC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MTM Clear Aligner is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Sirona. It received FDA 510(k) clearance on 2017-02-03 under 510(k) number K163155. 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 MTM Clear Aligner?

MTM Clear Aligner is a medical device that received FDA 510(k) clearance on 2017-02-03. The listed applicant is Dentsply Sirona. The 510(k) number is K163155.

When did MTM Clear Aligner receive FDA 510(k) clearance?

MTM Clear Aligner received FDA 510(k) clearance on 2017-02-03, under 510(k) number K163155.

Who is the listed applicant for MTM Clear Aligner?

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

What is the FDA product code for MTM Clear Aligner?

The FDA product code for MTM Clear Aligner is NXC.

Other records listing Dentsply Sirona 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.

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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

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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