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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Koncept Innovators, Inc.. It received FDA 510(k) clearance on 2026-05-14 under 510(k) 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. The listed applicant is Koncept Innovators, Inc.. The 510(k) number is K261134.

When did Dormiva Anti-Snoring Mouth Guard receive FDA 510(k) clearance?

Dormiva Anti-Snoring Mouth Guard received FDA 510(k) clearance on 2026-05-14, under 510(k) number K261134.

Who is the listed applicant for Dormiva Anti-Snoring Mouth Guard?

The FDA 510(k) record lists Koncept Innovators, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Dormiva Anti-Snoring Mouth Guard?

The FDA product code for Dormiva Anti-Snoring Mouth Guard is LRK.

Related Clinical Trials

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.

NCT04092660Increasing the Use of an Anti-snoring Mouth Guard (Mandibular Advancement Appliance) to Prevent Upper Airway Collapse During Sleep in Patients With Obstructive Sleep Apnoea.RECRUITING

Other records listing Koncept Innovators, Inc. as applicant

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.

K201484Somnos Anti-Snoring Mouth GuardK181099Bright Guard

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, LLCK252942ShaeferHShaeferh, LLCK253845Anti Snoring Mouthpiece (L08-BP, L08-PT, L08-BT, L08-TP, L08-TB, L08-PB)Ram.Shaw Pte. , Ltd.K252531Myosa (S1H, S1, S2, S3, S1M, S2M); Myosa for Snorers (S1, S1M, S2)Myofunctional Research Co.

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.

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