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FDA 510(k)

Mandibular Advancement Device L07

K-Number: K251628 · 2025-10-22

ApplicantDcstar, Inc.
Decision Date2025-10-22
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Mandibular Advancement Device L07 is a medical device manufactured by Dcstar, Inc.. It received FDA 510(k) clearance on 2025-10-22 under approval number K251628. 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 Mandibular Advancement Device L07?

Mandibular Advancement Device L07 is a medical device that received FDA 510(k) clearance on 2025-10-22. It is manufactured by Dcstar, Inc.. The 510(k) number is K251628.

When was Mandibular Advancement Device L07 approved by the FDA?

Mandibular Advancement Device L07 received FDA 510(k) clearance on 2025-10-22, under approval number K251628.

What company makes Mandibular Advancement Device L07?

Mandibular Advancement Device L07 is manufactured by Dcstar, Inc..

What is the FDA product code for Mandibular Advancement Device L07?

The FDA product code for Mandibular Advancement Device L07 is LRK.

Related Clinical Trials

NCT07606495 Impact on Prognosis of Increased Sleep Quality Obtained by Personalized Night-time Nursing Care in Critically Ill Patients NOT_YET_RECRUITING NCT07103941 IOA Preventing Occlusal Changes With MAD Use RECRUITING NCT07591025 Comparison Between Mandibular Advancement With Aligners and Twin Block in Class II Malocclusion in Growing Patients COMPLETED NCT06970171 Acceptance of Mandibular Advancement Devices ENROLLING_BY_INVITATION NCT04092660 Increasing 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 NCT05477719 Effect of Compression Stockings on the Number of Apneas/Hypopneas Per Hour of Sleep in Patients With Syndrome Obstructive Sleep Apnea/Hypopnea as Compared to no Treatment COMPLETED

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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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