DRY MOUTH MOUTHWASH

K111250 · Dr. Fresh, Inc. · LFD · Apr 27, 2012 · DE

Device Facts

• Record ID: K111250
• Device Name: DRY MOUTH MOUTHWASH
• Applicant: Dr. Fresh, Inc.
• Product Code: LFD · DE
• Decision Date: Apr 27, 2012
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

Relieves the symptoms of dry mouth, cleans, soothes oral irritation, lubricates and moisturizes dry mouth irritation and diminishes dry discomfort. Indications for Use: Relieves the symptoms of dry mouth, while moisturizing and lubricating oral dryness.

Device Story

Dr. Fresh Dry Mouth Mouthwash is an artificial saliva substitute formulated with moisturizers, humectants, and salivary enzymes. It is designed for over-the-counter use to relieve xerostomia symptoms by lubricating, moisturizing, and soothing oral irritation. The liquid solution is supplied in PET bottles (1.5 oz, 16 oz, 33.8 oz) and applied topically to the oral cavity as needed. By mimicking natural saliva, the rinse provides symptomatic relief from dry mouth discomfort.

Clinical Evidence

No clinical data. Biocompatibility testing performed in accordance with ISO 10993, demonstrating compliance for irritation, cytotoxicity, and contact sensitization.

Technological Characteristics

Liquid artificial saliva substitute containing moisturizers, humectants, and salivary enzymes. Non-sterile. Packaged in PET bottles. Biocompatibility tested per ISO 10993.

Indications for Use

Indicated for patients experiencing symptoms of dry mouth (xerostomia) to provide moisturizing and lubrication of oral dryness.

Predicate Devices

• Biotene Dry Mouth Oral Rinse (K101477)

Submission Summary (Full Text)

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KIII 250

PRIVATE LABEL DRYMOUTH RINSE DR. FRESH, INC.

510(K) Summary: Product Code LFD

| <b>1. Submitter Information</b> | |
|-----------------------------------------|----------------------------------------------|
| Name: | Dr. Fresh, Inc. |
| Address: | 6645 Caballero Blvd.<br>Buena Park, CA 90620 |
| Contact Person: | Gary Pendyala |
| Telephone: | 714.690.1573 Office<br>714.690.1572 FAX |
| <b>2. Device Name</b> | |
| Device Name: | Dry Mouth Mouthwash |
| Trade or Proprietary Name: | Dr. Fresh Dry Mouth Mouthwash |
| Common or Usual Name: | Saliva, Artificial |
| Classification Name: | Saliva, Artificial |
| <b>3. Identification of Equivalence</b> | |

GlaxoSmithKline Consumer Healthcare Biotene Dry Mouth Oral Rinse (K101477)

### Device Description 4.

Dr. Fresh Dry Mouth Mouthwash is a specifically formulated artificial saliva substitute which contains moisturizers, humectants and patent pending salivary enzymes that have lubricating, moisturizing and soothing properties to relieve the symptoms of Dry Mouth. The liquid product is supplied in 1.5 oz, 16 oz and 33.8 oz PET bottles.

### ನ. Statement of Intended Use

Relieves the symptoms of dry mouth, cleans, soothes oral irritation, lubricates and moisturizes dry mouth irritation and diminishes dry discomfort. Indications for Use: Relieves the symptoms of dry mouth, while moisturizing and lubricating oral dryness.

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### Summary of Technological Characteristics 6. Characteristics of the Device Compared to the Predicate Device

| Product | Dr. Fresh Dry Mouth<br>Mouthwash | Biotene Dry Mouth Oral Rinse |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Relieves the symptoms of dry<br>mouth, cleans, soothes oral<br>irritation, lubricates and<br>moisturizes dry mouth irritation<br>and diminishes dry discomfort. | Relieves and treats the symptoms<br>of dry mouth; refreshes mouth<br>odors, cleans soothes oral<br>irritations, moisturizes, lubricates,<br>and diminishes dry discomfort |
| Dosage | As Needed<br>One tablespoon for every use | As Needed<br>One tablespoon for every use |
| Disease State | Xerostomia | Xerostomia |
| Packaging | 1.5 oz, 16 oz and 33.8 oz PET<br>bottles with flip caps | 16 OZ brick shaped white PETE<br>bottle with flip cap |
| Functional<br>Ingredients | See Ingredient Comparison<br>chart in Substantial Equivalence<br>Discussion | See Ingredient Comparison chart<br>in Substantial Equivalence<br>Discussion |
| Area of Use | Oral Cavity | Oral Cavity |
| Type of Product | Liquid Solution | Liquid Solution |
| Presentation | Non-Sterile | Non-Sterile |

# SUBSTANTIAL EQUIVALENCE COMPARISON CHART

### 7. Biocompatibility .

Dr. Fresh Dry Mouth Mouthwash has been tested in accordance with ISO 10993 and was shown to meet the requirements of biocompatibility testing in the categories of irritation, cytotoxicity and contact sensitization.

### 8. · Discussion and Conclusion

Based on the comparison of intended use and technical characteristics, we conclude that Dr. Fresh Dry Mouth Mouthwash is substantially equivalent to the predicate device.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features the department's name in a circular arrangement around a stylized eagle emblem. The eagle is depicted with its wings spread, symbolizing protection and service. The overall design is simple and professional, reflecting the department's role in public health and welfare.

### Public Health Service

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

APR 2 7 2012

Dr. Fresh. Inc. C/O Ms. Camille Thornton Senior Regulatory Specialist Registrar Corp 144 Research Drive Hampton, Virginia 23666

Re: K111250

Trade/Device Name: Dry Mouth Mouthwash Regulation Number: Unclassified Regulation Name: None Regulatory Class: Unclassified Product Code: LFD Dated: October 25, 2011 Received: March 28, 2012

Dear Ms. Thornton:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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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## Page 2 - Ms. Thornton

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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Suen Ruans

Anthony D. Watson, B.S., M.S., M.B.A. 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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K III 250

# Indications for Use

510(k) Number (if known): N/A

Device Name: Dry Mouth Mouthwash

Indications For Use:

Relieves the symptoms of dry mouth, while moisturizing and lubricating oral dryness.

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

Over-The-Counter Use: X (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)

Susan Runner

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

510(k) Number: