REMOVABLE ARYLIC HERBST, ALLESEE SNORE APPLIANCE (ASA), AND ENOCH SNORINATOR

K070327 · Sybron Dental Specialties, Inc. · LRK · May 25, 2007 · Dental

Device Facts

• Record ID: K070327
• Device Name: REMOVABLE ARYLIC HERBST, ALLESEE SNORE APPLIANCE (ASA), AND ENOCH SNORINATOR
• Applicant: Sybron Dental Specialties, Inc.
• Product Code: LRK · Dental
• Decision Date: May 25, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.5570
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The intended use of the Removable Acrylic Herbst is for the reduction of snoring and mild to moderate obstructive sleep apnea (OSA) by moving the lower jaw into a prescribed relationship to the upper jaw. The intended use of the Enoch Snorinator is for the reduction of snoring and mild to moderate obstructive sleep apnea (OSA) by moving the lower jaw into a prescribed relationship to the upper jaw. The intended use of the Allesee Snore Appliance (ASA) is for the reduction of snoring and mild to moderate obstructive sleep apnea (OSA) by moving the lower jaw into a prescribed relationship to the upper jaw.

Device Story

Devices are intraoral appliances for snoring and mild to moderate OSA; prescribed by dentists. Removable Acrylic Herbst: upper/lower arch system; stainless steel telescoping Herbst mechanism; bilateral; supports lower jaw in dentist-determined anterior position. Enoch Snorinator: one-piece upper arch splint; pressure-formed; anterior ramp postures lower jaw forward. Allesee Snore Appliance (ASA): one-piece upper/lower pressure-formed splint; joined by orthodontic acrylic; rectangular airway; postures lower jaw forward. All devices function by mechanically repositioning the mandible to increase airway passage; patient-specific advancement determined by clinician. Benefits include reduced snoring and improved airway patency during sleep.

Clinical Evidence

No clinical data provided; substantial equivalence based on design, intended use, and comparison to legally marketed predicate devices.

Technological Characteristics

Intraoral appliances; materials include orthodontic acrylic and stainless steel (Herbst mechanism). Form factors include one-piece pressure-formed splints or two-piece arch systems with telescoping rods. Mechanical principle: mandibular advancement via physical positioning. No software or energy source.

Indications for Use

Indicated for patients with snoring and mild to moderate obstructive sleep apnea (OSA) 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

• Removable Herbst Appliance (State University of New York at Buffalo, School of Dental Medicine)
• Snore Guard (Hays & Meade Inc.)
• NAPA Appliance (Great Lakes Orthodontic Laboratory)

Submission Summary (Full Text)

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K070327

Image /page/0/Picture/1 description: The image shows a logo for Sybron Dental Specialties. The logo features the letters 'sds' in a stylized font, with a curved line above them. Below the letters, the words 'SYBRON DENTAL SPECIALTIES' are printed in a bold, sans-serif font. The word 'Submitter:' is printed below the company name.

MAY 2 5 2007

Allesee Orthodontic Appliances, Inc. 13931 Spring Street Sturtevant, WI 53177

Contact: Sybron Dental Specialties, Inc. 1717 W. Collins Avenue Orange, California 92867 [phone] - Phone [phone] - Facsimile Colleen Boswell - Contact Person Date Summary Prepared: May 2007

#### Device Name:

- Trade Name Removable Acrylic Herbst .
- . Common Name - Intraoral Device for Snoring and/or Sleep Apnea
- Classification Name Intraoral Device for Snoring and Intraoral Device for Snoring and � Obstructive Sleep Apnea, per 21 CFR § 872.5570

Devices for Which Substantial Equivalence is Claimed:

- State University of New York at Buffalo, School of Dental Medicine, Removable Herbst . Appliance
#### Device Description:

The Removable Acrylic Herbst appliance is an upper and lower arch system designed to hold the lower jaw forward which increases the lower airway passage and reduces the tendency to snore. The upper and lower appliances are connected by means of a telescoping male and female stainless steel tube (upper) and rod (lower) Herbst mechanism. 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 degree to which the patient's lower jaw is supported in an anterior position is determined by the dentist.

#### Intended Use of the Device:

The intended use of the Removable Acrylic Herbst is for the reduction of snoring and mild to moderate obstructive sleep apnea (OSA) by moving the lower jaw into a prescribed relationship to the upper jaw.

#### Substantial Equivalence:

The Removable Acrylic Herbst is substantially equivalent to another legally marketed device in the United States. The Removable Acrylic Herbst is used in a manner similar to the Removable Herbst Appliance developed by the State University of NY at Buffalo, School of Dental Medicine.

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# K070327

Image /page/1/Picture/1 description: The image shows the logo for Sybron Dental Specialties. The logo features the letters 'sds' in a stylized, bold font, with a curved line above the letters. Below the letters, the words 'SYBRON DENTAL SPECIALTIES' are written in a smaller, sans-serif font. The logo is black and white.

#### Submitter:

Allesee Orthodontic Appliances, Inc. 13931 Spring Street Sturtevant, WI 53177

Contact:

Sybron Dental Specialties, Inc. 1717 W. Collins Avenue Orange, California 92867 [phone] - Phone [phone] - Facsimile Colleen Boswell - Contact Person Date Summary Prepared: May 2007

#### Device Name:

- . Trade Name - Enoch Snorinator
- . Common Name - Intraoral Device for Snoring and/or Sleep Apnea
- . Classification Name - Intraoral Device for Snoring and Intraoral Device for Snoring and Obstructive Sleep Apnea, per 21 CFR § 872.5570

Devices for Which Substantial Equivalence is Claimed:

- . Hays & Meade Inc., Snore Guard
#### Device Description:

The Enoch Snorinator is a one-piece appliance designed for the upper arch only. It is a pressureformed anterior repositioning splint which postures the lower jaw forward to alleviate snoring. The anterior portion is formed into a "ramp" shape to engage the lower incisors. This ramp postures the lower jaw into the prescribed position as determined by the dentist.

#### Intended Use of the Device:

The intended use of the Enoch Snorinator is for the reduction of snoring and mild to moderate obstructive sleep apnea (OSA) by moving the lower jaw into a prescribed relationship to the upper jaw.

#### Substantial Equivalence:

The Enoch Snorinator is substantially equivalent to another legally marketed device in the United States. The Enoch Snorinator is used in a manner similar to the Snore Guard appliance developed by Hays & Meade Inc.

> 1717 West Collins Avenue, Orange, CA 92867 800-537-7824 714-516-7400

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# 070327

Image /page/2/Picture/1 description: The image shows the logo for Sybron Dental Specialties. The logo features the letters 'sds' in a stylized font, with a curved line above them. Below the letters, the words 'SYBRON DENTAL SPECIALTIES' are printed in a bold, sans-serif font. The word 'Submitter:' is printed below the company name.

Allesee Orthodontic Appliances, Inc. 13931 Spring Street Sturtevant, WI 53177

Contact:

Sybron Dental Specialties, Inc. 1717 W. Collins Avenue Orange, California 92867 [phone] - Phone [phone] - Facsimile Colleen Boswell - Contact Person Date Summary Prepared: May 2007

#### Device Name:

- . Trade Name - Allesee Snore Appliance (ASA)
- . Common Name - Intraoral Device for Snoring and/or Sleep Apnea
- Classification Name Intraoral Device for Snoring and Intraoral Device for Snoring and ● Obstructive Sleep Apnea, per 21 CFR § 872.5570

#### Devices for Which Substantial Equivalence is Claimed:

- . Great Lakes Orthodontic Laboratory, NAPA Appliance
#### Device Description:

The Allesee Snore Appliance (ASA) is a one-piece upper and lower, pressure-formed splint. The upper and lower jaw plastic appliances are joined together with orthodontic acrylic. The appliance postures the patient's lower jaw in a forward or anterior position. The amount of advancement is patient specific and determined by the dentist. The appliance has a rectangular airway between the upper and lower anterior teeth.

#### Intended Use of the Device:

The intended use of the Allesee Snore Appliance (ASA) is for the reduction of snoring and mild to moderate obstructive sleep apnea (OSA) by moving the lower jaw into a prescribed relationship to the upper jaw.

#### Substantial Equivalence:

The Allesee Snore Appliance (ASA) is substantially equivalent to another legally marketed device in the United States. The Allesee Snore Appliance (ASA) is used in a manner similar to the NAPA Appliance produced by Great Lakes Orthodontic Laboratory.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/3/Picture/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name arranged in a circular pattern around a central emblem. The emblem consists of a stylized caduceus-like symbol, with three human profiles facing right, stacked on top of each other. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Colleen Boswell Vice President, Regulatory Affairs Sybron Dental Specialties, Incorporated 1717 West Collins Avenue Orange, California 92867

MAY 2 5 2007

Re: K070327

Trade/Device Name: Removable Acrylic Herbst, Allesee Snore Appliance (ASA), and Enoch Snorinator 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: May 11, 2007 Received: May 14, 2007

Dear Ms. Boswell:

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 - Ms. Boswell

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 (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.

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,

Suyite y. Michie Omp.

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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## K070327

### Indications for Use

#### 510(k) Number (if known): K070327

Device Name: Removable Acrylic Herbst

#### Indications for Use:

The Removable Acrylic Herbst is intended to be used for the reduction of snoring and mild to moderate obstructive sleep apnea (OSA) by repositioning the lower jaw into a prescribed relationship to the upper jaw.

Prescription Use

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

RSBer DOS for Dr. Susan Runner

ospital

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K070327

### Indications for Use

510(k) Number (if known): K070327

Device Name: Allesee Snore Appliance (ASA)

Indications for Use:

The Allesee Snore Appliance (ASA) is intended to be used for the reduction of snoring and mild to moderate obstructive sleep apnea (OSA) by repositioning the lower jaw into a prescribed relationship to the upper jaw.

× Prescription Use

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Robert Betz DDS for Dr Susan Runner

Hospital

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# 70327

### Indications for Use

510(k) Number (if known): K070327

Device Name: Enoch Snorinator

#### Indications for Use:

The Enoch Snorinator is intended to be used for the reduction of snoring and mild to modcrate obstructive sleep apnea (OSA) by repositioning the lower jaw into a prescribed relationship to the upper jaw.

Prescription Use

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Robert Betz DDS for Dr. Susan Rummer

Hospital

310(k): K070327