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FDA 510(k)

uLab Systems Dental Aligner Kit

K-Number: K211510 · 2022-02-24

ApplicantUlab Systems, Inc.
Decision Date2022-02-24
Product CodeNXC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

uLab Systems Dental Aligner Kit is the device name listed in this FDA 510(k) record. The listed applicant is Ulab Systems, Inc.. It received FDA 510(k) clearance on 2022-02-24 under 510(k) number K211510. 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 uLab Systems Dental Aligner Kit?

uLab Systems Dental Aligner Kit is a medical device that received FDA 510(k) clearance on 2022-02-24. The listed applicant is Ulab Systems, Inc.. The 510(k) number is K211510.

When did uLab Systems Dental Aligner Kit receive FDA 510(k) clearance?

uLab Systems Dental Aligner Kit received FDA 510(k) clearance on 2022-02-24, under 510(k) number K211510.

Who is the listed applicant for uLab Systems Dental Aligner Kit?

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

What is the FDA product code for uLab Systems Dental Aligner Kit?

The FDA product code for uLab Systems Dental Aligner Kit is NXC.

Other records listing Ulab Systems, 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.

K200772ULab Systems uDesign SoftwareK192596ULab Systems Dental Aligner KitK171295ULab Systems Treatment Planning Software

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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