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FDA 510(k)

SmileAlign Orthodontic Aligner System

K-Number: K191774 · 2019-09-30

Applicant3D Global Biotech, Inc.
Decision Date2019-09-30
Product CodeNXC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SmileAlign Orthodontic Aligner System is the device name listed in this FDA 510(k) record. The listed applicant is 3D Global Biotech, Inc.. It received FDA 510(k) clearance on 2019-09-30 under 510(k) number K191774. 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 SmileAlign Orthodontic Aligner System?

SmileAlign Orthodontic Aligner System is a medical device that received FDA 510(k) clearance on 2019-09-30. The listed applicant is 3D Global Biotech, Inc.. The 510(k) number is K191774.

When did SmileAlign Orthodontic Aligner System receive FDA 510(k) clearance?

SmileAlign Orthodontic Aligner System received FDA 510(k) clearance on 2019-09-30, under 510(k) number K191774.

Who is the listed applicant for SmileAlign Orthodontic Aligner System?

The FDA 510(k) record lists 3D Global Biotech, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SmileAlign Orthodontic Aligner System?

The FDA product code for SmileAlign Orthodontic Aligner System is NXC.

Other records listing 3D Global Biotech, 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.

K212803DailyMate Orthodontic Aligner System

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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