THE MOSES ELITE APPLIANCE

K132933 · Allen J. Moses, Dds, Ltd. · LRK · Apr 25, 2014 · Dental

Device Facts

• Record ID: K132933
• Device Name: THE MOSES ELITE APPLIANCE
• Applicant: Allen J. Moses, Dds, Ltd.
• Product Code: LRK · Dental
• Decision Date: Apr 25, 2014
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.5570
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Moses Elite appliance is intended for use on adult patients 18 years of age and older as an aid for the reduction and/or alleviation of snoring and mild to moderate obstructive sleep apnea.

Device Story

The Moses Elite Appliance is an intraoral device designed to treat snoring and mild to moderate obstructive sleep apnea (OSA). It functions by positioning the mandible to maintain airway patency during sleep. The device is prescribed by a dentist or physician and is intended for use by the patient at home. By advancing the mandible, the appliance helps prevent airway collapse, thereby reducing snoring and OSA symptoms. It serves as a mechanical aid for patients, improving sleep quality and reducing health risks associated with sleep-disordered breathing.

Clinical Evidence

No clinical data provided; substantial equivalence is based on device design and intended use.

Technological Characteristics

Intraoral mandibular advancement device. Mechanical design for airway management. Materials and construction are consistent with standard dental appliance specifications for class II intraoral devices.

Indications for Use

Indicated for adult patients 18 years of age and older for the reduction and/or alleviation of 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

Public Health Service

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

April 25, 2014

Allen J. Moses, DDS Allen J. Moses DDS, Limited 233 South Wacker Drive Chicago, IL 60606

Received: April 1, 2014

Re: K132933

Trade/Device Name: The Moses™ Elite Appliance 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: LRK Dated: March 29, 2014

Dear Dr. Moses:

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 - Dr. Moses

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevicesfor You/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Susan Russo DDS, MA

Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

510(k) Number (if known)

K132933

Device Name

The Moses Elite appliance

Indications for Use (Describe)

The Moses Elite appliance is intended for use on adult patients 18 years of age and older as an aid for the reduction and/or alleviation of snoring and mild to moderate obstructive sieep apnea.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

[ ] Over-The-Counter Use (21 CFR 801 Subpart C)

# PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON A SEPARATE PAGE IF NEEDED.

#### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Andrew I. Steen -S 2014.04.25 08:30:29 -04'00'

FORN FDA 3881 (1/14)

**PEC Publishing Services [phone]** **EF**

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