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FDA 510(k)

Smylic Invisible Clear Aligners

K-Number: K173784 · 2018-08-23

ApplicantSmylio, Inc.
Decision Date2018-08-23
Product CodeNXC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Smylic Invisible Clear Aligners is the device name listed in this FDA 510(k) record. The listed applicant is Smylio, Inc.. It received FDA 510(k) clearance on 2018-08-23 under 510(k) number K173784. 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 Smylic Invisible Clear Aligners?

Smylic Invisible Clear Aligners is a medical device that received FDA 510(k) clearance on 2018-08-23. The listed applicant is Smylio, Inc.. The 510(k) number is K173784.

When did Smylic Invisible Clear Aligners receive FDA 510(k) clearance?

Smylic Invisible Clear Aligners received FDA 510(k) clearance on 2018-08-23, under 510(k) number K173784.

Who is the listed applicant for Smylic Invisible Clear Aligners?

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

What is the FDA product code for Smylic Invisible Clear Aligners?

The FDA product code for Smylic Invisible Clear Aligners is NXC.

Other records listing Smylio, 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.

K260788Smylio AlignersK221537Nightwear AlignersK212660Smylio Invisible Clear Aligners

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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