ORAL BALANCE LIQUID/ GEL

K061331 · Laclede, Inc. · LFD · Jul 25, 2006 · DE

Device Facts

• Record ID: K061331
• Device Name: ORAL BALANCE LIQUID/ GEL
• Applicant: Laclede, Inc.
• Product Code: LFD · DE
• Decision Date: Jul 25, 2006
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

A refreshing Gel and Liquid that quickly diminishes dry discomfort, mouth odors and other symptoms of a dry mouth.

Device Story

Oral Balance Gel and Liquid is an artificial saliva substitute designed to alleviate symptoms of xerostomia. The product contains a formulation of moisturizers, amino acids, milk proteins, and patented salivary enzymes that provide lubricating and moistening properties to the oral cavity. It is supplied in a bottle and tube for topical application. The device is intended for use by patients suffering from dry mouth to provide symptomatic relief. It is an over-the-counter product applied as needed to the oral cavity.

Clinical Evidence

Bench testing only. Studies included acute oral toxicity, eye irritation, and preservative effectiveness testing to demonstrate safety and efficacy for the intended use.

Technological Characteristics

Lipid solution containing moisturizers, amino acids, milk proteins, and patented salivary enzymes. Non-sterile. Supplied in 1.5 oz bottle and tube. No electronic or software components.

Indications for Use

Indicated for patients experiencing dry mouth (xerostomia) symptoms, including dry discomfort and mouth odors.

Predicate Devices

• Caphasol (K991938)
• Salivart (K981693)
• Salinum or Oraclair (K024148)
• TGC Spray (K051812)

Submission Summary (Full Text)

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HEALTHCARE PRODUCTS DIVISION

East University Drive, Rancho Domir guez, CA 90220 Fax: [phone] • http: //www.laclede.com Phone: [phone] ·

K061331

510(k) Summary

May 8, 2006

- 1. Submission Applicant & Correspondent: Name: Address:
Phone No .: Contact Person: Laclede, Inc.

2103 E. University Dr. Rancho Dominguez, Ca 90220

[phone] Michael Pellico, President

## 2. Name of Device:

ORAL BALANCE GEL AND LIQUID

Trade/Proprietary/Model Name: Common or Usual Name: Classification Names:

ORAL BALANCE GEL AND LIQUID Dental: Saliva, Artificial Dental: Saliva, Artificial

3. Regulatory Information: Device Class: Product Code:

Unclassified LFD

4. Devices to which new device is substantially equivalent:

Inpharma AB: Gebauer Company: Sinclair Pharmaceuticals Laboratoires Carilene S.A.S. Caphasol cleared in K991938 Salivart cleared in K981693 Salinum or Oraclair cleared in K024148 TGC Spray cleared in K051812

5. Device Description:

Oral Balance is an artificial saliva substitute which contains moisturizers, amino acids, milk proteins that have lubricating and moistening properties, it also contains patented salivary enzymes. Product is supplied in 1.5 oz PI.T bottle and tube.

K18

DE

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HEALTHCARE PRODUCTS DIVISION

2103 East University Drive, Rancho Dominguez, CA 90220 2103 East University Drive, Ranono Bomings222 • • http: //www.laclede.com

6. Intended Use of the Device:

A refreshing Gel and Liquid that quickly diminishes dry discomfort, mouth odors and other symptoms of a dry mouth.

7. Summary of Technological Characteristics of the Device compared to the Predicate Devices:

Substantial Equivalence Comparison Chart

| Product | Oral Balance | TGO Spray | Caphasol | Salivart | Salinum/Oraclair |
|----------------------|-------------------------------------|-------------------------------------|-------------------------------------|-------------------------------------|-------------------------------------|
| Intended Use | Symptomatic Treatment of xerostomia | Symptomatic Treatment of xerostomia | Symptomatic Treatment of xerostomia | Symptomatic Treatment of xerostomia | Symptomatic Treatment of xerostomia |
| Method of Use | Ready to use liquid and Gel | Ready to use spray | Mix parts A &B ampoules | Ready to use spray | Ready to use ampoules |
| Applications per Day | As needed | As needed | As needed | As needed | As needed |
| Disease State | Xerostomia | Xerostomia | Xerostomia | Xerostomia | Xerostomia |
| Area of Use | Oral Cavity | Oral Cavity | Oral Cavity | Oral Cavity | Oral Cavity |
| Type of Product | Lipid solution | Lipid solution | Electrolyte solution | Electrolyte solution | Lipid solution |
| Presentation | Non-Sterile | Non-Sterile | Non-Sterile | Non-Sterile | Non-Sterile |

8. Tests and conclusion:

Oral Balance formulation has been shown in studies, including tests for acute oral toxicity, Oral Balance formulation has book chown the eve inritation and preservative effectiveness to be safe and effective for its indented use.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Michael A. Pellico President Laclede, Incorporated 2103 East University Drive Rancho Domingucz, California 90220

Re: K061331

Trade/Device Name: Oral Balance Liquid and Gel Regulation Number: Unclassified Regulation Name: None Regulatory Class: None Product Code: LFD Dated: May 8, 2006 Received: May 12, 2006

Dear Mr. Pellico:

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.

JUL 25 2006

If your device is classified (see above) into cither 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. Pellico

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 (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/cdrlv/industry/support/index.html.

Sincerely vours,

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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## Indications for Use

510(k) Number (if known):

K041331

Device Name: Oral Balance Liquid and Gel

Indications For Use:

A Refreshing Gel and Liquid that quickly diminishes dry discomfort, mouth odors, and other symptoms of a Dry Mouth.

Prescription Use -(Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use
(21 CFR 801 Subpart C) ✓

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Robert J. Betz DDS for Dr. Susan Runner
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Control, Dental Devices
Number K061331

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