EndSnorZ Sleep Appliance
K-Number: K211069 · 2021-10-26
ApplicantPrismatik Dentalcraft, Inc.
Decision Date2021-10-26
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
EndSnorZ Sleep Appliance is a medical device manufactured by Prismatik Dentalcraft, Inc.. It received FDA 510(k) clearance on 2021-10-26 under approval number K211069. The device is classified under product code LRK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the EndSnorZ Sleep Appliance?
EndSnorZ Sleep Appliance is a medical device that received FDA 510(k) clearance on 2021-10-26. It is manufactured by Prismatik Dentalcraft, Inc.. The 510(k) number is K211069.
When was EndSnorZ Sleep Appliance approved by the FDA?
EndSnorZ Sleep Appliance received FDA 510(k) clearance on 2021-10-26, under approval number K211069.
What company makes EndSnorZ Sleep Appliance?
EndSnorZ Sleep Appliance is manufactured by Prismatik Dentalcraft, Inc..
What is the FDA product code for EndSnorZ Sleep Appliance?
The FDA product code for EndSnorZ Sleep Appliance is LRK.
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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.