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FDA 510(k)

Tuxedo Digital Dental Sensor

K-Number: K153710 · 2016-03-18

ApplicantLed Dental, Inc.
Decision Date2016-03-18
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Tuxedo Digital Dental Sensor is a medical device manufactured by Led Dental, Inc.. It received FDA 510(k) clearance on 2016-03-18 under approval number K153710. The device is classified under product code MQB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Tuxedo Digital Dental Sensor?

Tuxedo Digital Dental Sensor is a medical device that received FDA 510(k) clearance on 2016-03-18. It is manufactured by Led Dental, Inc.. The 510(k) number is K153710.

When was Tuxedo Digital Dental Sensor approved by the FDA?

Tuxedo Digital Dental Sensor received FDA 510(k) clearance on 2016-03-18, under approval number K153710.

What company makes Tuxedo Digital Dental Sensor?

Tuxedo Digital Dental Sensor is manufactured by Led Dental, Inc..

What is the FDA product code for Tuxedo Digital Dental Sensor?

The FDA product code for Tuxedo Digital Dental Sensor is MQB.

Related Clinical Trials

NCT07613658 3D-Printed Versus Band-and-Loop Versus Denovo Space Maintainers in Primary Dentition. NOT_YET_RECRUITING NCT07608302 Comparison of the Predictability of Dentoalveolar Expansion With Two Clear Aligner Systems COMPLETED NCT06938412 Exercise Activity Intervention With Sensor-Based Engagement in Patients With Atrial Fibrillation RECRUITING NCT07599202 Comparison of Laboratory-Fabricated and 3D-Printed Rapid Maxillary Expansion Appliances ACTIVE_NOT_RECRUITING NCT07232667 Digital Technology for Active and Healthy Ageing in Taiwan RECRUITING NCT07586163 Effectiveness of Clear Aligner Systems in Mixed Dentition Maxillary Transverse Deficiency ACTIVE_NOT_RECRUITING

Related PubMed Literature

PMID: 40942702 Digital Cardiovascular Twins, AI Agents, and Sensor Data: A Narrative Review from System Architecture to Proactive Heart Health. Sensors (Basel, Switzerland) (2025)

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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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