ORAL NEUTRALIZER

K071617 · Oral Biotech · LFD · Oct 19, 2007 · DE

Device Facts

• Record ID: K071617
• Device Name: ORAL NEUTRALIZER
• Applicant: Oral Biotech
• Product Code: LFD · DE
• Decision Date: Oct 19, 2007
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

A refreshing gel, liquid, or spray that diminishes dry oral discomfort, neutralizes mouth odors, neutralizes and moisturizes oral biofilm, and other symptoms of a chronic or temporary dry mouth/xerostomia as a result of disease such as Sjogren's Syndrome, oral inflammation, medication, chemo or radiotherapy, stress, or aging.

Device Story

Oral Neutralizer is an artificial saliva substitute formulated as a gel, liquid, or spray. It provides lubricating, neutralizing, and moistening properties to the oral cavity to alleviate symptoms of xerostomia. The device is intended for over-the-counter use by patients to manage dry oral discomfort, neutralize mouth odors, and moisturize oral biofilm. It is applied topically to the oral cavity as needed.

Clinical Evidence

Bench testing only. Functional and performance evaluations were conducted to assess the safety and effectiveness of the liquid, gel, and spray formulations, with all results reported as satisfactory.

Technological Characteristics

Artificial saliva substitute provided as a gel, liquid, or spray. Non-sterile presentation. Formulated for topical application to the oral cavity. No electronic components, energy sources, or software algorithms.

Indications for Use

Indicated for patients experiencing chronic or temporary dry mouth (xerostomia) due to Sjogren's Syndrome, oral inflammation, medication, chemo/radiotherapy, stress, or aging.

Predicate Devices

• Oral Balance Gel and Liquid (K061331)
• Caphasol (K991938)
• Salivart (K981693)
• Salinum or Oraclair (K024148)
• TGO Spray (K051812)

Submission Summary (Full Text)

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K071617

OCT 1 9 2007

Oral BioTech Oral Neutralizer Original Premarket 510(K) Notification

### SECTION 9: 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

This 510(K) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR.807.92.

## 9.1 SUBMITTER INFORMATION

| a. Submitter Name: | Oral BioTech Inc. |
|----------------------------------------------------|---------------------------------------|
| b. Submitter Address: | 812 Water St. NE<br>Albany OR 97321 |
| c. Submitter Telephone:<br>d. Submitter Facsimile: | [phone]<br>[phone] |
| e. Contact Person: | Bob Bowers<br>Chief Operating Officer |
| f. Date Summary Prepared: | May 31, 2007 |
| 9.2 DEVICE IDENTIFICATION | |

#### Oral Neutralizer a. Trade/Proprietary Name: b. Classification Name: Dental: Saliva, Artificial Unclassified

### 9.3 IDENTIFICATION OF PREDICATE DEVICES

The Oral Neutralizer by Oral BioTech is substantially equivalent to:

| Laclede, Inc: | Oral Balance Gel and Liquid in K061331 |
|------------------------------|----------------------------------------|
| Inpharma AB: | Caphasol in K991938 |
| Gebauer Company: | Salivart in K981693 |
| Sinclair Pharmacuticals: | Salinum or Oraclair in K024148 |
| Laboratories Carilene S.A.S: | TGO Spray in K051812 |

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Oral BioTech Oral Neutralizer Original Premarket 510(K) Notification

#### 9.4 DEVICE DESCRIPTION

Oral Neutralizer, like the mentioned pre existing devices, is an artificial saliva substitute which, like natural saliva, contains lubricating, neutralizing, and moistening properties to help alleviate the symptoms of dry mouth (xerostomia).

### 9.5 SUBSTANTIAL EQUIVALENCE/TECHNOLOGICAL CHARACTERISTICS

Summary of technological characteristics of the device as compared to the predicate devices:

| Product | Oral<br>Neutralizer | Oral<br>Balance | TGO Spray | Caphesol | Salivart | Salinum/Oraclair |
|-------------------------|-------------------------------------------|-------------------------------------------|-------------------------------------------|-------------------------------------------|-------------------------------------------|-------------------------------------------|
| Intended Use | Symptomatic<br>Treatment of<br>Xerostomia | Symptomatic<br>Treatment of<br>Xerostomia | Symptomatic<br>Treatment of<br>Xerostomia | Symptomatic<br>Treatment of<br>Xerostomia | Symptomatic<br>Treatment of<br>Xerostomia | Symptomatic<br>Treatment of<br>Xerostomia |
| Method of Use | Ready to use<br>liquid, gel,<br>spray | Ready to<br>use Liquid<br>and gel | Ready to<br>use spray | Mix parts<br>A&B<br>ampoules | Ready to<br>use spray | Ready to use<br>liquid/rinse |
| Applications per<br>Day | As needed | As needed | As needed | As needed | As needed | As needed |
| Disease State | Xerostomia | Xerostomia | Xerostomia | Xerostomia | Xerostomia | Xerostomia |
| Area of Use | Oral Cavity | Oral Cavity | Oral Cavity | Oral Cavity | Oral Cavity | Oral Cavity |
| Type of product | Gel, solution | Gel, solution | solution | solution | solution | solution |
| Presentation | Non-Sterile | Non-Sterile | Non-Sterile | Non-Sterile | Non-Sterile | Non-Sterile |

### 9.6 INDICATIONS FOR USE

A refreshing gel, liquid, or spray that diminishes dry oral discomfort, neutralizes mouth odors, neutralizes and moisturizes oral biofilm, and other symptoms of a chronic or temporary dry mouth/xerostomia as a result of disease such as Sjogren's Syndrome, oral inflammation, medication, chemo or radiotherapy, stress, or aging.

#### 9.7 TESTS AND CONCLUSIONS

Functional and performance evaluation has been conducted to assess the safety and effectiveness of Oral Neutralizer liquid, gel, and spray. All results are satisfactory.

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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 depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The logo is surrounded by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 9 2007

Mr. Robert Bowers Chief Operating Officer Oral BioTech, Incorporated 812 Water Street, North East Albany, Oregon 97321

Re: K071617

Trade/Device Name: Oral Neutralizer Regulation Number: Unclassified Regulation Name: None Regulatory Class: Unclassified Product Code: LFD Dated: August 22, 2007 Received: September 7, 2007

Dear Mr. Bowers:

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 - Mr. Bowers

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. er mo receir any 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,

Susan Runoe
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

Page 1 of 1

510(k) Number K071617_

Oral Neutralizer _____________________________________________________________________________________________________________________________________________________________ Device Name___________________________________________________________________________________________________________________________________________________________________

Indications for use:

A refreshing gel, liquid, or spray that diminishes dry oral discomfort, neutralizes mouth odors, neutralizes and moisturizes oral biofilm, and other symptoms of a chronic or temporary dry mouth/xerostomia as a result of disease such as Sjogren's Syndrome, oral inflammation, medication, chemo or radiotherapy, stress, or aging.

Do not write below this line - Continue on another page if needed

Prescription Use (Per 21 CFR 801.109)

OR

Over the counter X

(Optional Format 1-2-96)

Susan Runner

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

*10(k) Number: K07167