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FDA 510(k)

Vivid Aligners

K-Number: K190003 · 2019-11-06

ApplicantOrthodent Laboratory, Inc.
Decision Date2019-11-06
Product CodeNXC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Vivid Aligners is the device name listed in this FDA 510(k) record. The listed applicant is Orthodent Laboratory, Inc.. It received FDA 510(k) clearance on 2019-11-06 under 510(k) number K190003. 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 Vivid Aligners?

Vivid Aligners is a medical device that received FDA 510(k) clearance on 2019-11-06. The listed applicant is Orthodent Laboratory, Inc.. The 510(k) number is K190003.

When did Vivid Aligners receive FDA 510(k) clearance?

Vivid Aligners received FDA 510(k) clearance on 2019-11-06, under 510(k) number K190003.

Who is the listed applicant for Vivid Aligners?

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

What is the FDA product code for Vivid Aligners?

The FDA product code for Vivid Aligners is NXC.

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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