MILLENIUM ANTI-SNORING DEVICE

K112627 · Millenium Dental Laboratory, Inc. · LQZ · Jun 6, 2012 · Dental

Device Facts

• Record ID: K112627
• Device Name: MILLENIUM ANTI-SNORING DEVICE
• Applicant: Millenium Dental Laboratory, Inc.
• Product Code: LQZ · Dental
• Decision Date: Jun 6, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.5570
• Device Class: Class 2
• Attributes: Therapeutic

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 Story

Millenium Anti-Snoring Device is an intraoral appliance designed to treat snoring and mild to moderate obstructive sleep apnea. Device functions by repositioning the mandible to maintain airway patency during sleep. Used by adult patients; prescribed by clinicians. Output is physical airway support; clinical decision-making involves patient management of sleep-disordered breathing. Benefits include reduction in snoring and apnea events.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Intraoral mandibular advancement device. Materials and specific dimensions not detailed in provided text. Mechanical principle of operation for airway maintenance.

Indications for Use

Indicated for adult patients with snoring and mild to moderate obstructive sleep apnea.

Regulatory Classification

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.

Special Controls

*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.”

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Mr. Nghiep V. Nguyen Owner Millenium Dental Laboratory, Incorporation 18056 Waco Drive NW Ramsey, Minnesota 55303

JUN - 6 2012

Re: K112627

Trade/Device Name: Millenium Anti-Snoring Device Regulation Number: 21 CFR 872.5570 Regulation Name: Intraoral Devices for Snoring and Intraoral Devices For Snoring

And Obstructive Sleep Apnea

Regulatory Class: II Product Code: LQZ Dated: May 18, 2012 Received: May 23, 2012

Dear Mr. Nguyen:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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## Page 2 - Mr. Nguyen

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Nh for

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

## Enclosure

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## Indications for Use

510(k) Number (if known):

Device Name: Millenium Anti-Snoring Device

Indications For 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.

Prescription Use _ X

AND/OR

Over-The-Counter Use

(21 CFR 801 Subpart C)

(Part 21 CFR 801 Subpart D)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Super Roases

Page 1 of

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: