IST SNORING APPLIANCE

K090911 · Dental Crafters · LQZ · Sep 11, 2009 · Dental

Device Facts

• Record ID: K090911
• Device Name: IST SNORING APPLIANCE
• Applicant: Dental Crafters
• Product Code: LQZ · Dental
• Decision Date: Sep 11, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.5570
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The IST Snoring Appliance is a dentist prescribed intraoral device for repositioning the upper and lower jaw into a prescribed relationship in single patient for multi-use at home or sleep laboratories.

Device Story

Intraoral appliance; two-piece upper and lower arch system; custom-fit by dentist. Uses telescoping stainless steel tube (upper) and rod (lower) mechanism (ISTplus) to posture lower jaw forward. Increases lower airway passage; alleviates snoring. Used at home or sleep labs; patient-operated. Dentist determines jaw position. Mechanical design allows limited mouth opening/closing while maintaining anterior jaw support.

Technological Characteristics

Custom-fit acrylic arches; stainless steel telescoping male/female tube and rod mechanism (ISTplus). Bilateral system. Mechanical mandibular advancement. No software or electronics.

Indications for Use

Indicated for persons 18 years or older, who wish to reduce the incidence of snoring and/or 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.”

Predicate Devices

• Endsnor (K072731)
• Removable Arylic Herbst Allesee Snore (K070327)
• TAP® III (K062951)

Submission Summary (Full Text)

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SEP 1 1 2009

K090911

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#### Attachment 6

## 510(k) SUMMARY Dental Crafter's IST Device

### Submitter's Name, Address, Telephone Number, Contact Person

Robert Slominski Co-Owner 1000 Corporate Drive PO Box 770 Marshfield, WI 54449 715/387-2642 800/472-8302 715/387-4100 (fax) [e-mail]

Date Prepared:

## Name of Device: IST Snoring Appliance

Name/Address of Sponsor

Common or Usual Name: Apnea and Anti-Snoring Device

Classification Name: Anti-Snoring Device

Predicate Devices:

Endsnor (K072731)

Removable Arylic Herbst Allesee Snore (K070327)

TAP® III (K062951)

Intended Use: The IST Snoring Appliance is a dentist prescribed intraoral device for repositioning the upper and lower jaw into a prescribed relationship in single patient for multi-use at home or sleep laboratories.

Indications for Use: The IST Snoring Appliance is indicated for persons 18 years or older, who wish to reduce the incidence of snoring and/or mild to moderate obstructive sleep apnea.

#### Technological Characteristics and Substantial Equivalence:

The Dental Crafters' IST Snoring Appliance is a dentist prescribed intraoral device for repositioning the upper and lower jaw into a prescribed relationship in single patient for multiuse at home or sleep laboratories.

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K090911

The Dental Crafters' IST Snoring Appliance is a 2 piece upper and lower arch system designed to posture the lower jaw forward which increases the lower airway passage and alleviates snoring. It is custom-fit to a patient's teeth by a professional dentist. The upper and lower appliances are connected by means of a telescoping male and female stainless steel tube (upper) and rod (lower) ISTplus mechanism produced by Dr Hinz Dental. The acrylic arches of the appliance are secured to the occlusal surface. The system is bilateral, left and right. While the patient can open and close their mouth, the lower jaw arcs as predetermined by the construction of the appliance. The dentist determines the position in which the lower jaw is supported in an anterior position.

The Company's anti-snoring device covered by this submission is substantially equivalent to other legally marketed Anti-Snoring Devices. Specifically, the Dental Crafters' IST Snoring Appliance is substantially equivalent to Endsnor (K072731), Removable Arylic Herbst Allesee Snore (K070327), and TAP® III (K062951). IST has the same general intended use, similar principles of operation, and similar technological characteristics as the previously cleared predicate devices

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three bars representing its wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular fashion around the eagle. The eagle is facing to the right. The logo is black and white.

SEP 1 1 2009

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

Ms. Amy Nystrom Chief Financial Officer Dental Crafters 1000 Corporate Drive PO Box 770 Marshfield, Wisconsin 54449

Re: K090911

Trade/Device Name: IST Snore Appliance

· Regulation Number: 872.5570

Regulation Name: Intraoral Devices for Snoring and Intraoral Devices for Snoring and Obstructive Sleep Apnea

Regulatory Class: II Product Code: LOZ Dated: September 2, 2009 Received: September 4, 2009

Dear Ms. Nystrom:

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 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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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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

for

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

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K090911

Attachment 8

510(k) Number (if known):

Device Name: IST Snore Appliance

Indications for Use:

The IST Snoring Appliance is a dentist prescribed intraoral device for repositioning the upper and lower jaw into a prescribed relationship in single patient for multi-use at home or sleep laboratories. It is indicated for persons 18 years or older, who wish to reduce the incidence of snoring and/or mild to moderate obstructive sleep apnea.

## (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER LINE IF NECESSARY0

# Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Ophthalmic & ENT Devices

or

510(k) Number

ઋ Prescription Use

Over-The-Counter Use (Optional Format 1-2-96)

EyeIC Additional Information for K March 17. 2009 Page 1 of

Susan Ringer

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

510(k) Number. K090911