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SomnoDent G2

by Somnomed, Inc.

510(k) K121340

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK121340 Date30 May 2012ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

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, 20 Sep 2026

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

The SomnoDent G2 is a dental oral appliance designed to treat obstructive sleep apnea (OSA) by maintaining an open airway during sleep. It functions as a mandibular advancement device, repositioning the lower jaw to prevent airway collapse and reduce snoring and apnea events. This Class II device is intended for use in patients with mild to moderate OSA who are unable or unwilling to use continuous positive airway pressure (CPAP).

The SomnoDent G2 is supplied as a single-use or reusable device, depending on the specific prescription and patient needs, and is regulated under FDA 510(k) clearance (K121340) as substantially equivalent to predicate devices. It is intended for use in dental offices and sleep clinics, with adjustments made by trained dental professionals. The device is not MRI-safe and must be stored in a clean, dry environment as per manufacturer guidelines. No additional regulatory approvals beyond the stated 510(k) clearance are referenced in the specifications.

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Questions

AI-generated answers, 20 Sep 2026

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

  • What is the primary purpose of the SomnoDent G2 and who is it designed for?

    The SomnoDent G2 is a dental oral appliance designed to treat obstructive sleep apnea (OSA) by repositioning the lower jaw to maintain an open airway during sleep. It is specifically intended for patients with mild to moderate OSA who are unable or unwilling to use continuous positive airway pressure (CPAP). The device is adjusted by trained dental professionals in dental offices or sleep clinics.

  • Can the SomnoDent G2 be reused, or is it meant for single-use only?

    The SomnoDent G2 can be supplied as either a single-use or reusable device, depending on the specific prescription and patient needs. This flexibility allows for customization based on clinical recommendations and patient requirements.

  • How should the SomnoDent G2 be stored to ensure its effectiveness and longevity?

    The SomnoDent G2 must be stored in a clean, dry environment as per manufacturer guidelines. Proper storage conditions help maintain its integrity and functionality for use in treating obstructive sleep apnea.

  • Is the SomnoDent G2 safe for use in an MRI environment?

    No, the SomnoDent G2 is explicitly stated as not MRI-safe. Patients should avoid MRI scans while using this device to prevent potential risks.

  • What regulatory pathway does the SomnoDent G2 follow, and what does this mean for its use?

    The SomnoDent G2 follows the FDA 510(k) clearance pathway, specifically classified as substantially equivalent to predicate devices under the regulatory category of dental appliances. This means it has been reviewed and cleared by the FDA for its intended use in treating mild to moderate obstructive sleep apnea, ensuring it meets established safety and performance standards.