Silent Nite sl
K-Number: K183270 · 2019-07-17
ApplicantPrismatik Dentalcraft, Inc.
Decision Date2019-07-17
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Silent Nite sl is a medical device manufactured by Prismatik Dentalcraft, Inc.. It received FDA 510(k) clearance on 2019-07-17 under approval number K183270. 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 sl?
Silent Nite sl is a medical device that received FDA 510(k) clearance on 2019-07-17. It is manufactured by Prismatik Dentalcraft, Inc.. The 510(k) number is K183270.
When was Silent Nite sl approved by the FDA?
Silent Nite sl received FDA 510(k) clearance on 2019-07-17, under approval number K183270.
What company makes Silent Nite sl?
Silent Nite sl is manufactured by Prismatik Dentalcraft, Inc..
What is the FDA product code for Silent Nite sl?
The FDA product code for Silent Nite sl is LRK.
Other Devices by Prismatik Dentalcraft, Inc.
Related Devices (Code: LRK)
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.