SomnoDent Avant
K-Number: K183443 · 2019-05-08
ApplicantSomnomed, Inc.
Decision Date2019-05-08
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
SomnoDent Avant is a medical device manufactured by Somnomed, Inc.. It received FDA 510(k) clearance on 2019-05-08 under approval number K183443. 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 SomnoDent Avant?
SomnoDent Avant is a medical device that received FDA 510(k) clearance on 2019-05-08. It is manufactured by Somnomed, Inc.. The 510(k) number is K183443.
When was SomnoDent Avant approved by the FDA?
SomnoDent Avant received FDA 510(k) clearance on 2019-05-08, under approval number K183443.
What company makes SomnoDent Avant?
SomnoDent Avant is manufactured by Somnomed, Inc..
What is the FDA product code for SomnoDent Avant?
The FDA product code for SomnoDent Avant is LRK.
Other Devices by Somnomed, 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.