Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

NightGuard Flex

K-Number: K212448 · 2021-11-12

ApplicantSprintray, Inc.
Decision Date2021-11-12
Product CodeMQC
DecisionSubstantially Equivalent

Device Summary

NightGuard Flex is a medical device manufactured by Sprintray, Inc.. It received FDA 510(k) clearance on 2021-11-12 under approval 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. It is manufactured by Sprintray, Inc.. The 510(k) number is K212448.

When was NightGuard Flex approved by the FDA?

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

What company makes NightGuard Flex?

NightGuard Flex is manufactured by Sprintray, Inc..

What is the FDA product code for NightGuard Flex?

The FDA product code for NightGuard Flex is MQC.

Other Devices by Sprintray, Inc.

K222623Digital Crown K221678SprintRay High Impact Denture Base K220979SprintRay Denture Base K230445OnX Tough K242559Digital Temp K242277Crown HT

View all 9 devices →

Related Devices (Code: MQC)

K170985Urbanek DeviceTmj Services, LLC K161884Ortho System3Shape A/S K191836Ceramill A-SplintAmann Girrbach AG K183598KeyPrint KeySplint SoftKeystone Industries K182820The PODAdvanced Facialdontics, LLC K190107VeriSplintWhip Mix Corporation

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.

↑