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K Number
K112627
Device Name
MILLENIUM ANTI-SNORING DEVICE
Manufacturer
MILLENIUM DENTAL LABORATORY, INC
Date Cleared
2012-06-06

(271 days)

Product Code
LQZ
Regulation Number
872.5570
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Millenium Anti-Snoring Device is indicated for use in the treatment of snoring and mild to moderate obstructive sleep apnea in adult patients.

Device Description

Not Found

AI/ML Overview

The provided FDA 510(k) summary for the Millenium Anti-Snoring Device explicitly states that the device is being cleared as "substantially equivalent" to legally marketed predicate devices. This type of clearance generally means that the submission does not typically include a detailed clinical study demonstrating the device meets specific performance acceptance criteria as would be required for a novel or high-risk device. Instead, the focus is on showing similarity to existing products.

Therefore, the document does not contain the information requested regarding acceptance criteria, a specific study proving device performance against those criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or detailed training set information.

The core information provided is:

  • Device Name: Millenium Anti-Snoring Device
  • Intended Use: Treatment of snoring and mild to moderate obstructive sleep apnea in adult patients.
  • Regulatory Status: Class II, regulated under 21 CFR 872.5570 for Intraoral Devices for Snoring and Intraoral Devices For Snoring And Obstructive Sleep Apnea.
  • Clearance Type: 510(k) substantial equivalence rather than a PMA (Premarket Approval) which would require more extensive clinical evidence.

§ 872.5570 Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea.

(a)
Identification. Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea are devices that are worn during sleep to reduce the incidence of snoring and to treat obstructive sleep apnea. The devices are designed to increase the patency of the airway and to decrease air turbulence and airway obstruction. The classification includes palatal lifting devices, tongue retaining devices, and mandibular repositioning devices.(b)
Classification. Class II (special controls). The special control for these devices is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intraoral Devices for Snoring and/or Obstructive Sleep Apnea; Guidance for Industry and FDA.”