SILENT PARTNER SERIES OSA APPLIANCES

K051014 · Dreamwrx Dental Laboratory · LRK · Aug 9, 2005 · Dental

Device Facts

• Record ID: K051014
• Device Name: SILENT PARTNER SERIES OSA APPLIANCES
• Applicant: Dreamwrx Dental Laboratory
• Product Code: LRK · Dental
• Decision Date: Aug 9, 2005
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 872.5570
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The device is intended to reduce nighttime snoring and/or mild to moderate obstructive sleep apnea by repositioning of the mandible.

Device Story

Silent Partner series OSA appliances are custom-fit, removable intraoral devices used to treat snoring and mild-to-moderate obstructive sleep apnea. The device consists of upper and lower dental trays connected by a mechanical attachment system. The practitioner determines the degree of mandibular advancement and vertical opening. The mechanism features a titanium stylus and a nine-position latched slider housed within a 16 mm titanium channel in the upper component; a 10 mm channel in the lower tray allows for lateral jaw excursion. The device is prescribed by a clinician and fitted by a dental professional. By holding the mandible in a forward position, the device helps maintain airway patency during sleep, potentially reducing apnea events and snoring. The patient can separate the trays for comfort and mouth breathing.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design, material, and functional comparisons to legally marketed predicate devices.

Technological Characteristics

Intraoral mandibular repositioning device. Materials: Vacuum-formed or thermoplastic trays; titanium stylus and slider mechanism. Design: Two-piece tray system with adjustable mandibular advancement and vertical opening. Connectivity: None. Sterilization: Not specified (intended for patient use).

Indications for Use

Indicated for patients with mild to moderate obstructive sleep apnea and/or snoring requiring mandibular repositioning.

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

• TOA (K972061)
• TAP (K962516)
• OASYS - Oral Airway System (K030440)

Submission Summary (Full Text)

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### 510(k) Summary

Silent Partner, K051014

| Date: | 3 August 2005 |
|-----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Applicant:<br>(Also manufacturing site) | DreamWRx Dental Laboratory<br>1911 Colorado Boulevard<br>Los Angeles, CA 90041 |
| Registration number: | 3005034462 |
| Contact person: | Nicolaas Besseling |
| Phone numbers:<br>(Contact person) | [phone] mobile<br>[phone] fax |
| Email address: | [e-mail] |
| Device name: | Silent Partner™ series OSA appliances |
| Common name: | Intraoral devices for snoring and obstructive sleep apnea |
| Classification: | Class II |
| Product Code: | LRK anti-snoring device |
| Regulation number: | 21CFR872.5570 |
| Predicate devices: | TOA, K972061<br>TAP, K962516<br>OASYS - Oral Airway System K030440 |
| Device description: | The device consists of a lower tray fitted over the lower teeth, an upper tray over the upper teeth, and a mechanism to attach the lower to the upper tray. The device allows the practitioner to determine the advancement of the mandible and the vertical opening for desired results. This technology platform consists of a stylus, slider, and the channels into which they are placed; these parts are identical in both models.<br>The device has a 10 mm long channel in the lower tray behind the anterior teeth that is perpendicular to the patient's tongue. This allows the upper component, which locks into the channel, to provide lateral excursion for the patient's comfort. Prior to final insertion the upper and lower trays are connected together by keying the stylus into the lower channel. The device's upper component consists of a 16 mm long titanium channel into which a nine-position latched slider will let the practitioner place the stylus in the optimum position. Both the slider and the stylus are placed into the channel's frontal opening and securely locked into place by tension attachment. |
| Intended use: | The device is intended to reduce nighttime snoring and/or mild to<br>moderate obstructive sleep apnea by repositioning of the mandible. |

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## Substantial equivalence comparison

| Device | Silent Part-<br>ner | TOA | TAP | OASYS |
|--------------------------------------------------------|-------------------------------|---------|---------|---------|
| Attribute | This submis-<br>sion, K051014 | K972061 | K962516 | K030440 |
| Intended use | | | | |
| Intraoral device | yes | yes | yes | yes |
| Reduce snoring | yes | yes | yes | yes |
| Reduce obstructive sleep apnea | yes | yes | yes | yes |
| Design | | | | |
| Removable device | yes | yes | yes | yes |
| Custom fit | yes | yes | yes | yes |
| Adjustable forward movement | yes | yes | yes | yes |
| Adjustable vertical movement | yes | no | no | no |
| Separate trays | yes | yes | yes | yes |
| Holds lower jaw forward | yes | yes | yes | yes |
| Permits lateral jaw movement | yes | yes | yes | yes |
| Permits vertical jaw movement | no | yes | yes | yes |
| Upper and lower trays can be sepa-<br>rated by patient | yes | yes | no | yes |
| Permits patient to breathe through<br>mouth | yes | yes | yes | yes |
| Specialized tools needed | no | no | no | yes |
| Materials | | | | |
| Vacuum formed trays | Model A | yes | yes | yes |
| Thermoplastic trays | Model B | yes | yes | yes |
| Ti stylus and critical parts | yes | no | no | no |

#### Conclusion

To the best of our knowledge, the device is substantially equivalent to the predicate devices, and no additional risks are created.

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Image /page/2/Picture/11 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features the department's name encircling a symbol. The symbol consists of a stylized caduceus-like design, with three human profiles facing right, representing health and human services.

AUG 9 - 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Nicolaas Besseling Principal DREAMWRX Dental Laboratory 1911 Colorado Blvd. Los Angeles, California 90041

Re: K051014

Trade/Device Name: Sleep Partner Series OSA Appliances Regulation Number: 21 CFR 872.5570 Regulation Name: Intraoral devices for snoring and obstructive sleep apnea Regulatory Class: II Product Code: LRK Dated: June 24, 2005 Received: June 30, 2005

Dear Mr. Besseling:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaon 310(t) promise is substantially equivalent (for the indications ferenect above and have active degally marketed predicate devices marketed in interstate for use stated in the enclosure) to regars annount date of the Medical Device Americants, or to commerce prior to May 20, 1976, the excordance with the provisions of the Federal Food, Drug, devices that have been recuire approval of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval application (PM and Cosmetic Act (Free) that ao not requent in the general controls provisions of the Act. The You may, therefore, market the devices, boyer is a courements for annual registration, listing of general controls provisions of the revelop 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 If your device is classified (500 above) and existing major regulations affecting your device can may be subject to such additional connections, Title 21, Parts 800 to 898. In addition, FDA may be found in the Code of Poderal Regarning your device in the Federal Register.

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### Page 2 -- Mr. Besseling

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issuation of a backen complies with other requirements of the Act
that FDA has made a determination that your device complies with other mast that FDA nas made a decidination administered by other Federal agencies. You must of any Federal statutes and regulations paintines on the not limited to: registration and listing (21 comply with all the Act s requirements, mercesses comments of the requirements as set CFK Part 807), labeling (21 CFR Part 800); god an art 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820); and 1000 (1050 forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Sections 091 - 15 described in your Section 510(k)
This letter will allow you to begin marketing your device as described in your besine I his letter will anow you to oegin manceing your antial equivalence of your device to a legally premarket nother. The PDA mining of basification 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 If you desire specific advice io. your as of [phone]. Also, please note the regulation entitled, a contact the Office of Compliance at (217) airfration" (21CFR Part 807.97). You may obtain "Misoranding by telefonecto promantes nowler the Act from the Division of Small other general Information on your responsive Assistance at its toll-free number [phone] or Manufacturers, International and Oolisanter Plastians overdrh/industry/support/index.html.

Sincerely yours.

Susa Runne

Image /page/3/Picture/4 description: The image shows a handwritten letter 'f' and the word 'or'. The letter 'f' is written in a cursive style. The word 'or' is written in a standard font.

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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# 3 Indications for use

| 510(k) number: | K051014 |
|----------------|---------------------------------------------------------------------------------------------------------------|
| Device name: | Silent Partner series OSA appliances |
| Intended use: | Reduce nighttime snoring and/or mild to moderate obstructive<br>sleep apnea by repositioning of the mandible. |

Concurrence of CDRH, Office of Device Evaluation

Prescription use
(Per 21CFR801.109)

or

ﻟﺮ

147

Over-The-Counter use

:

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(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices 1975 510(k) Number: _______________________________________________________________________________________________________________________________________________________________

Singa

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