LAIMAD

K062333 · Steven Lamberg, D.D.S · LRK · Dec 14, 2006 · Dental

Device Facts

• Record ID: K062333
• Device Name: LAIMAD
• Applicant: Steven Lamberg, D.D.S
• Product Code: LRK · Dental
• Decision Date: Dec 14, 2006
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 872.5570
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Lamberg Sleep Well device is intended to reduce night time snoring. The Lamberg Sleep Well device is indicated for use in adults 18 years of age or older in a home or sleep laboratory environment. The device must be prescribed by a dentist or physician.

Device Story

Custom-molded, one-piece mandibular advancement device; worn by patient in home or sleep lab. Device fits over upper incisors; central protrusive element contacts lingual lower incisors; Adams clasps secure device to upper first molars. Principle of operation: device advances mandible 5 mm; forward mandibular positioning pulls tongue forward; reduces snoring. Healthcare provider prescribes device; patient self-inserts and wears during sleep. Benefits patient by reducing snoring.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

One-piece, custom-molded intraoral device. Dimensions: 2–3 mm thick over upper incisors. Features central protrusive element for 5 mm mandibular advancement and Adams clasps for molar retention. Material: Denture base resin.

Indications for Use

Indicated for adults 18+ to reduce night time snoring. Used in home or sleep lab environments. Requires prescription by dentist or physician.

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.”

Predicate Devices

• TheraSnore (K973038)
• Hawley retainer (Preamendments)
• Trubyte Denture Base Resin System (K011560)
• Modification to Trubyte Denture Base Resin System (K032892)

Submission Summary (Full Text)

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Kevin Mulry, D.D.S. December 7, 2006 Page 9

Attachment 2: 510(k) Summary

## 510(k) SUMMARY

DEL 1 4 2006 Steven B. Lamberg, D.D.S.'s Lamberg Sleep Well Device

# Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

Hogan & Hartson LLP 555 Thirteenth Street, NW Washington, D.C. 20004-1109 Phone: [phone] Facsimile: 202-637-5910

Contact Person: Jonathan S. Kahan

Date Prepared:December 5, 2006

#### Name of Device /Address of Sponsor

Lamberg Sleep Well Device

Steven B. Lamberg, D.D.S. 140 Main Street Northport, New York 11768 Phone: [phone] Facsimile: 631-261-6364

#### Common or Usual Name

Mandibular advancement device

#### Classification Name

Anti-snoring device (Product code: LRK)

## Predicate Devices

TheraSnore (K973038) Distar, Inc.

Hawley retainer (Preamendments) Specialty Appliance Works, Inc.

Trubyte Denture Base Resin System, and Modification to Trubyte Denture Base Resin System Dentsply International (K011560, K032892)

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K062333

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Kevin Mulry, D.D.S. December 7, 2006 Page 10

## Intended Use / Indications for Use

The Lamberg Sleep Well device is intended to reduce night time snoring.

The Lamberg Sleep Well device is indicated for use in adults 18 years of age or older in a home or sleep laboratory environment.

#### Technological Characteristics

The Lamberg Sleep Well device is a one piece, custom-molded device that advances the mandible by 5 mm. The body of the device extends over the upper incisors, and is 2 – 3 mm thick. A central protrusive element hangs down to contact the lingual lower incisors. An Adams clasp is placed to hold the device securely to each of the upper first molars. The appliance ends at the distal of the first molars on the palate.

## Principles of Operation

The patient inserts the device into their mouth, seating it against the soft palate, and engages it securely to the upper front molars with the Adams clasps. The central protrusive element hangs down and makes contact with the lingual surface of the mandibular incisors, thus moving the mandible forward by 5 mm. The forward placement of the mandible with respect to the maxilla serves to pull the tongue forward, which directly and indirectly reduces snoring.

#### Performance Data

No performance data are required in support of this 510(k) notice.

## Substantial Equivalence

The Lamberg Sleep Well device is substantially equivalent in intended use and technology to the TheraSnore (K973038). The Lamberg Sleep Well device has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. The minor technological differences between the Lamberg Sleep Well device and its predicate devices raise no new issues of safety or effectiveness. Thus, the Lamberg Sleep Well device is substantially equivalent.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle. The eagle is black, and the text is also black.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Steven Lamberg, D.D.S C/O Mr. Jonathan S. Kahan Columbia Square Hogan & Hartson, L.L.P. 555 Thirteenth Street, NW Washington, DC 20004-1109 DEC 1 4 2006

Re: K062333 Trade/Device Name: Lamberg Sleep Well Device Regulation Number: 872.5570 Regulation Name: Intraoral Devices for Snoring and Intraoral Devices for Snoring and Obstructive Sleep Apnea Regulatory Class: II Product Code: LRK Dated: December 7, 2006 Received: December 7, 2006

Dear Mr. Kahan:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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. Lahan

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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/industry/support/index.html.

Sincerely yours,

Chris Liu, Ph.D.

Chiu Lin, Ph.D. 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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Kevin Mulry, D.D.S. December 7, 2006 Page 8

Attachment 1:

## Indications for Use Statement

510(k) Number: K062333

Device Name: Lamberg Sleep Well Device

Indications for Use:

The Lamberg Sleep Well device is intended to reduce night time snoring in adults 18 years of The Earlover of Sleep laboratory environment. The device must be prescribed by a dentist or physician.

Prescription Use _ X (Part 21 C.F.R. 801 Subpart D) AND/OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ (21 C.F.R. 807 Subpart C)

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| | <div> <span style="text-decoration: overline;">Susan Runner</span> </div> |
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| | n Control, Dental Devices |
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