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SilentNite

by Glidewell Laboratories

510(k) K972424

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

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 NumberK972424 Date18 Sep 1997ClearedStatusActive

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-2769-2026 FDA Class II initiated 27 Apr 2026

    Due to device not having FDA Clearance

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  • Withdrawn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, 22 Sep 2026

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

SilentNite is an anti-snoring device classified as a dental appliance. It is intended for use in snore prevention.

This device is authorized under FDA 510(k) clearance. It is a dental solution for sleep-disordered breathing.

Other devices from Glidewell Laboratories

Questions

AI-generated answers, 22 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 SilentNite device?

    SilentNite is a dental appliance specifically intended for use in snore prevention. It serves as a dental solution for patients experiencing sleep-disordered breathing.

  • Is the SilentNite device authorized for use?

    Yes, the device is authorized under FDA 510(k) clearance. This indicates that the manufacturer, Glidewell Laboratories, has received regulatory clearance for the device as a dental appliance.

  • What regulatory category does SilentNite fall under?

    SilentNite is classified as a dental appliance under regulation number 872.5570. It is categorized under the dental advisory committee and carries the product code LRK.