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Mandibular Advancement Device L07

by Dcstar, Inc. 510(k)

Active United States

510(k) K251628

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK251628 Date22 Oct 2025ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
LRK
Device Class
Class II
Regulation
21 CFR Part 872.5570
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

A Mandibular Advancement Device L07 is a dental anti-snoring device designed to treat snoring by repositioning the lower jaw forward during sleep. It is classified as a Class II medical device under FDA regulation 872.5570 and has been determined to be substantially equivalent to a predicate device.

The device is supplied by Dcstar, Inc. and received FDA 510(k) clearance (K251628) on October 22, 2025, following a traditional review process. It is intended for use in dental settings and is not described as sterile, single-use, reusable, or MRI-safe in the provided data. No specific sizes, storage conditions, or additional authorizations beyond the FDA 510(k) clearance are specified in the device data.

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