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FDA 510(k)

THERMOFORMED MOUTHGUARDS

K-Number: K121365 · 2012-11-20

ApplicantGlidewell Laboratories-Sleep Devices Group
Decision Date2012-11-20
Product CodeMQC
DecisionSubstantially Equivalent

Device Summary

THERMOFORMED MOUTHGUARDS is the device name listed in this FDA 510(k) record. The listed applicant is Glidewell Laboratories-Sleep Devices Group. It received FDA 510(k) clearance on 2012-11-20 under 510(k) number K121365. The device is classified under product code MQC. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THERMOFORMED MOUTHGUARDS?

THERMOFORMED MOUTHGUARDS is a medical device that received FDA 510(k) clearance on 2012-11-20. The listed applicant is Glidewell Laboratories-Sleep Devices Group. The 510(k) number is K121365.

When did THERMOFORMED MOUTHGUARDS receive FDA 510(k) clearance?

THERMOFORMED MOUTHGUARDS received FDA 510(k) clearance on 2012-11-20, under 510(k) number K121365.

Who is the listed applicant for THERMOFORMED MOUTHGUARDS?

The FDA 510(k) record lists Glidewell Laboratories-Sleep Devices Group as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for THERMOFORMED MOUTHGUARDS?

The FDA product code for THERMOFORMED MOUTHGUARDS is MQC.

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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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