FDA 510(k)

NightGuard Flex

K-Number: K212448 · 2021-11-12

Decision Date2021-11-12

Product CodeMQC

DecisionSubstantially Equivalent

Device Summary

NightGuard Flex is the device name listed in this FDA 510(k) record. The listed applicant is Sprintray, Inc.. It received FDA 510(k) clearance on 2021-11-12 under 510(k) number K212448. The device is classified under product code MQC. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NightGuard Flex?

NightGuard Flex is a medical device that received FDA 510(k) clearance on 2021-11-12. The listed applicant is Sprintray, Inc.. The 510(k) number is K212448.

When did NightGuard Flex receive FDA 510(k) clearance?

NightGuard Flex received FDA 510(k) clearance on 2021-11-12, under 510(k) number K212448.

Who is the listed applicant for NightGuard Flex?

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

What is the FDA product code for NightGuard Flex?

The FDA product code for NightGuard Flex is MQC.

Other records listing Sprintray, Inc. as applicant

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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.