SleepTight Mouthpiece STZ
K-Number: K191618 · 2019-12-11
ApplicantMichael D Williams Dds PA
Decision Date2019-12-11
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
SleepTight Mouthpiece STZ is a medical device manufactured by Michael D Williams Dds PA. It received FDA 510(k) clearance on 2019-12-11 under approval number K191618. 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 SleepTight Mouthpiece STZ?
SleepTight Mouthpiece STZ is a medical device that received FDA 510(k) clearance on 2019-12-11. It is manufactured by Michael D Williams Dds PA. The 510(k) number is K191618.
When was SleepTight Mouthpiece STZ approved by the FDA?
SleepTight Mouthpiece STZ received FDA 510(k) clearance on 2019-12-11, under approval number K191618.
What company makes SleepTight Mouthpiece STZ?
SleepTight Mouthpiece STZ is manufactured by Michael D Williams Dds PA.
What is the FDA product code for SleepTight Mouthpiece STZ?
The FDA product code for SleepTight Mouthpiece STZ is LRK.
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.