SALIVART ORAL MOISTURIZER MODEL NUMBER 03866-009-75 SALIVART ORAL MOISTURIZER MODEL NUMBER 0386-000-25

K981693 · Gebauer Co. · LFD · Aug 6, 2001 · DE

Device Facts

• Record ID: K981693
• Device Name: SALIVART ORAL MOISTURIZER MODEL NUMBER 03866-009-75 SALIVART ORAL MOISTURIZER MODEL NUMBER 0386-000-25
• Applicant: Gebauer Co.
• Product Code: LFD · DE
• Decision Date: Aug 6, 2001
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

An oral moisturizer which temporarily relieves the discomfort of dry mouth (xerostomia) and dry throat naturally. Salivart may be used to replace human saliva, when the amount of saliva normally secreted has been reduced. Salivart lubricates the mouth and throat to soothe discomfort and assist in speaking and swallowing. Salivart relieves dry mouth caused by certain medications, therapeutic treatments, diseases, normal aging and emotional factors.

Device Story

Salivart Oral Moisturizer is an OTC aqueous electrolyte solution containing a viscosity agent and an emulsifier. The solution is aerosolized using a nitrogen propellant and dispensed from a can. It is intended for use by patients suffering from xerostomia to lubricate the mouth and throat, providing temporary relief from dryness and assisting with speaking and swallowing. The device functions as a saliva substitute to soothe discomfort caused by medications, disease, or aging. It is a self-administered product.

Technological Characteristics

Aqueous electrolyte solution with viscosity agent and emulsifier. Aerosol delivery system using nitrogen propellant. No flavor or preservatives. Standalone device.

Indications for Use

Indicated for patients experiencing dry mouth (xerostomia) or dry throat due to medications, therapeutic treatments, diseases, aging, or emotional factors, requiring saliva replacement or lubrication to assist in speaking and swallowing.

Predicate Devices

• MOI-STIR® Mouth Moistener

Submission Summary (Full Text)

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AUG - 6 2001

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Pharmaceutical Preparations

UMMARY

Establishment Name:

Gebauer Company (Specification Developer of Salivart®)

Phone Number:

Fax Number:

Address:

Contact Person:

Date Summary Prepared:

Device Name:

Classification Name:

Predicate Product:

9410 St. Catherine Ave. Cleveland, OH 44104

[phone]

[phone]

Denise E. Spellman (Official Correspondent)

5/12/98

Salivart® Oral Moisturizer

Artificial Saliva

MOI-STIR® Mouth Moistener

## Device Description:

Salivart Oral Moisturizer, an OTC device, is an aqueous electrolyte solution containing a viscosity agent and an emulsifier. The solution is aerosolized with a nitrogen propellant. It comes in two different can sizes. The smaller size is both sold and used as a promotional sample.

## Intended Use of Device:

An oral moisturizer which temporarily relieves the discomfort of dry mouth (xerostomia) and dry throat naturally. Salivart may be used to replace human saliva, when the amount of saliva normally secreted has been reduced. Salivart lubricates the mouth and throat to soothe discomfort and assist in speaking and swallowing. Salivart relieves dry mouth caused by certain medications, therapeutic treatments, diseases, normal aging and emotional factors.

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# COMPARISON OF TECHNOLOGICAL CHARACTERISTICS:

Moi-Stir® Mouth Moistener and Salivart Oral® Moisturizer are essentially the same. They use the same chemical components with the exception of a flavor and two preservatives used by Moi-Stir. Salivart uses neither a flavor nor preservatives. The only other difference between the two products is the method of dispensing. Moi-Stir uses a pump mechanism and Salivart uses an aerosol mechanism. Therefore, the products are substantially equivalent.

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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 features a stylized image of an eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle image.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Denise E. Spellman ·Director, QA & Regulatory Affairs (Official Correspondent) Gebauer Company 9410 St. Catherine Avenue Cleveland, Ohio 44104

K981693 Re : Salivart® Oral Moisturizer Model Number Trade Name: 03866-009-75 Saliva Unclassified Requlatory Class: Product Code: LFD Dated: May 12, 1998 Received: May 13, 1998

Dear Ms. Spellman

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 reqistration, 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

AUG - 6 2001

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Page 2 - Ms. Spellman

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address

"http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

S. Dutman for

Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

Salivart® Oral Moisturizer Device Name: _________________________________________________________________________________________________________________________________________________________________

#### Indications For Use:

An oral moisturizer which temporarily relieves the discomfort of dry mouth (xerostomia) and dry throat naturally. Salivart may be used to replace human saliva, when the amount of saliva normally secreted has been reduced. Salivart lubricates the mouth and throat to soothe discomfort and assist in speaking and swallowing. Salivart relieves dry mouth caused by certain medications, therapeutic treatments, diseases, normal aging and emotional factors.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | <div style="display:inline-block; width:30px;"></div> | OR | Over-The-Counter Use | <div style="display:inline-block; width:30px;"></div> | (Optional Format 1-2-96) |
|------------------|-------------------------------------------------------|----|----------------------|-------------------------------------------------------|--------------------------|
|------------------|-------------------------------------------------------|----|----------------------|-------------------------------------------------------|--------------------------|

| | <div align="center"> <i>Suran Runn</i> <br/>(Division Sign-Off) <br/>Division of Dental, Infection Control, <br/>and General Hospital Devices </div> |
|---------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | <i>K9811693</i> |

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