Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Michael D Williams Dds PA. It received FDA 510(k) clearance on 2019-12-11 under 510(k) 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. The listed applicant is Michael D Williams Dds PA. The 510(k) number is K191618.

When did SleepTight Mouthpiece STZ receive FDA 510(k) clearance?

SleepTight Mouthpiece STZ received FDA 510(k) clearance on 2019-12-11, under 510(k) number K191618.

Who is the listed applicant for SleepTight Mouthpiece STZ?

The FDA 510(k) record lists Michael D Williams Dds PA as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SleepTight Mouthpiece STZ?

The FDA product code for SleepTight Mouthpiece STZ is LRK.

Related Devices (Code: LRK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261912SnØreNegatØrDnB Innovations, LLCK261366VirtusSomnomed, Inc.K261251Snorbliss® Anti-Snoring DeviceEndeavor Commerce, LLCK261134Dormiva Anti-Snoring Mouth GuardKoncept Innovators, Inc.K252942ShaeferHShaeferh, LLCK253845Anti Snoring Mouthpiece (L08-BP, L08-PT, L08-BT, L08-TP, L08-TB, L08-PB)Ram.Shaw Pte. , Ltd.

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.

↑