Silent Nite Sleep Appliance with the Glidewell Hinge
K-Number: K210694 · 2021-06-16
ApplicantPrismatik Dentalcraft, Inc.
Decision Date2021-06-16
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Silent Nite Sleep Appliance with the Glidewell Hinge is a medical device manufactured by Prismatik Dentalcraft, Inc.. It received FDA 510(k) clearance on 2021-06-16 under approval number K210694. 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 Silent Nite Sleep Appliance with the Glidewell Hinge?
Silent Nite Sleep Appliance with the Glidewell Hinge is a medical device that received FDA 510(k) clearance on 2021-06-16. It is manufactured by Prismatik Dentalcraft, Inc.. The 510(k) number is K210694.
When was Silent Nite Sleep Appliance with the Glidewell Hinge approved by the FDA?
Silent Nite Sleep Appliance with the Glidewell Hinge received FDA 510(k) clearance on 2021-06-16, under approval number K210694.
What company makes Silent Nite Sleep Appliance with the Glidewell Hinge?
Silent Nite Sleep Appliance with the Glidewell Hinge is manufactured by Prismatik Dentalcraft, Inc..
What is the FDA product code for Silent Nite Sleep Appliance with the Glidewell Hinge?
The FDA product code for Silent Nite Sleep Appliance with the Glidewell Hinge 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.