Dormiva Anti-Snoring Mouth Guard
K-Number: K261134 · 2026-05-14
ApplicantKoncept Innovators, Inc.
Decision Date2026-05-14
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Dormiva Anti-Snoring Mouth Guard is a medical device manufactured by Koncept Innovators, Inc.. It received FDA 510(k) clearance on 2026-05-14 under approval number K261134. 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 Dormiva Anti-Snoring Mouth Guard?
Dormiva Anti-Snoring Mouth Guard is a medical device that received FDA 510(k) clearance on 2026-05-14. It is manufactured by Koncept Innovators, Inc.. The 510(k) number is K261134.
When was Dormiva Anti-Snoring Mouth Guard approved by the FDA?
Dormiva Anti-Snoring Mouth Guard received FDA 510(k) clearance on 2026-05-14, under approval number K261134.
What company makes Dormiva Anti-Snoring Mouth Guard?
Dormiva Anti-Snoring Mouth Guard is manufactured by Koncept Innovators, Inc..
What is the FDA product code for Dormiva Anti-Snoring Mouth Guard?
The FDA product code for Dormiva Anti-Snoring Mouth Guard is 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.