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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 a medical device manufactured by Ulab Systems, Inc.. It received FDA 510(k) clearance on 2022-02-24 under approval 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. It is manufactured by Ulab Systems, Inc.. The 510(k) number is K211510.

When was uLab Systems Dental Aligner Kit approved by the FDA?

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

What company makes uLab Systems Dental Aligner Kit?

uLab Systems Dental Aligner Kit is manufactured by Ulab Systems, Inc..

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

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

Related Clinical Trials

NCT07608302 Comparison of the Predictability of Dentoalveolar Expansion With Two Clear Aligner Systems COMPLETED NCT07103941 IOA Preventing Occlusal Changes With MAD Use RECRUITING NCT07586163 Effectiveness of Clear Aligner Systems in Mixed Dentition Maxillary Transverse Deficiency ACTIVE_NOT_RECRUITING NCT05883202 Effect of the Abutment-Prosthesis Connection on Marginal Bone Loss and Gingival Sealing Around Dental Implants SUSPENDED NCT07420777 Investigate the Effectiveness of 3D-printed Shape Memory Aligners in the Treatment of Anterior Open Bite RECRUITING NCT06960161 Exploring the Use of Phototherapy to Improve CPAP Compliance RECRUITING

Related PubMed Literature

PMID: 40774046 Strengthening Dental Materiovigilance: A Review of International Reporting Frameworks. International dental journal (2025)

Other Devices by Ulab Systems, Inc.

K171295ULab Systems Treatment Planning Software K200772ULab Systems uDesign Software K192596ULab Systems Dental Aligner Kit

Related Devices (Code: NXC)

K151965Dentti SystemMartz, Inc. K162609ClearPath AlignerClearpath Orthodontics, Ltd. K163155MTM Clear AlignerDentsply Sirona K1636893M Clear Tray Aligner3M Unitek Corporation K1831593M Clarity Aligners3M Company K182329SureCure Orthodontic Aligner SystemDigital Orthodontic Care

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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