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SUAD Device

by Strong Dental, Inc.

510(k) K023836

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 · Abbreviated NumberK023836 Date8 Jul 2003ClearedStatusActive

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  • Withdrawn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)

Full name
The Suad Device
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, 19 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 SUAD Device is a dental sleep appliance classified as an anti-snoring device. It is designed to reposition the mandible (lower jaw) forward to dilate the upper airway, reducing snoring and obstructive sleep apnea symptoms by improving airflow during sleep.

This device is intended for single-use or reusable application in a dental setting, though specific sterility or reuse instructions are not detailed in the provided data. It is regulated under FDA 510(k) clearance (K023836) as substantially equivalent to predicate devices, with no explicit MRI safety or size specifications noted. Distribution is managed by Strong Dental, Inc., and the device falls under the dental medical specialty classification.

Questions

AI-generated answers, 19 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 SUAD Device in a clinical setting?

    The SUAD Device is designed as an anti-snoring dental appliance to reposition the mandible (lower jaw) forward. This action dilates the upper airway, helping to reduce snoring and alleviate symptoms of obstructive sleep apnea by improving airflow during sleep.

  • Is the SUAD Device intended for single-use or reusable applications, and what are the sterility considerations?

    The SUAD Device is labeled for single-use or reusable application in a dental setting. However, the provided data does not specify explicit sterility protocols or reuse instructions, so clinical practices should follow established dental infection control guidelines for either scenario.

  • How is the SUAD Device regulated by the FDA, and what does its classification mean for clinicians?

    The SUAD Device holds FDA 510(k) clearance (K023836) under the classification of Class II (LRK product code), meaning it is deemed substantially equivalent to a predicate device. This classification indicates it undergoes regulatory oversight to ensure safety and effectiveness for its intended use as an anti-snoring dental appliance.

  • Are there any available size variations or customization options for the SUAD Device?

    The provided data does not detail specific size variations, customization options, or sizing specifications for the SUAD Device. Clinicians should confirm sizing requirements with Strong Dental, Inc., as fit may vary based on patient anatomy and dental needs.

  • Who is responsible for distributing the SUAD Device, and how can clinicians obtain it?

    Distribution of the SUAD Device is managed by Strong Dental, Inc. (address: 21525 Ridgetop Cir., Suite 320, Sterling, VA 20166). Clinicians should contact the manufacturer directly for purchasing information, as no distribution channels or ordering details are specified in the provided data.