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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 the device name listed in this FDA 510(k) record. The listed applicant is Led Dental, Inc.. It received FDA 510(k) clearance on 2016-03-18 under 510(k) 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. The listed applicant is Led Dental, Inc.. The 510(k) number is K153710.

When did Tuxedo Digital Dental Sensor receive FDA 510(k) clearance?

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

Who is the listed applicant for Tuxedo Digital Dental Sensor?

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

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

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

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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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