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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 the device name listed in this FDA 510(k) record. The listed applicant is Dcstar, Inc.. It received FDA 510(k) clearance on 2025-10-22 under 510(k) 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. The listed applicant is Dcstar, Inc.. The 510(k) number is K251628.

When did Mandibular Advancement Device L07 receive FDA 510(k) clearance?

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

Who is the listed applicant for Mandibular Advancement Device L07?

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

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

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

Other records listing Dcstar, 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.

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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.

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