SleepRight Select-Comfort Dental Guard
K-Number: K212767 · 2021-12-22
Device Summary
SleepRight Select-Comfort Dental Guard is a medical device manufactured by Splintek, Inc.. It received FDA 510(k) clearance on 2021-12-22 under approval number K212767. The device is classified under product code MQC. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the SleepRight Select-Comfort Dental Guard?
SleepRight Select-Comfort Dental Guard is a medical device that received FDA 510(k) clearance on 2021-12-22. It is manufactured by Splintek, Inc.. The 510(k) number is K212767.
When was SleepRight Select-Comfort Dental Guard approved by the FDA?
SleepRight Select-Comfort Dental Guard received FDA 510(k) clearance on 2021-12-22, under approval number K212767.
What company makes SleepRight Select-Comfort Dental Guard?
SleepRight Select-Comfort Dental Guard is manufactured by Splintek, Inc..
What is the FDA product code for SleepRight Select-Comfort Dental Guard?
The FDA product code for SleepRight Select-Comfort Dental Guard is MQC.
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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.