BIOTENE ORAL BALANCE GEL, BIOTENE DRY MOUTH ORAL RINSE, BIOTENE MOISTURIZING MOUTH SPRAY

K123731 · Glaxosmithkline Consumer Healthcare (Gskch) · LFD · Jan 4, 2013 · DE

Device Facts

• Record ID: K123731
• Device Name: BIOTENE ORAL BALANCE GEL, BIOTENE DRY MOUTH ORAL RINSE, BIOTENE MOISTURIZING MOUTH SPRAY
• Applicant: Glaxosmithkline Consumer Healthcare (Gskch)
• Product Code: LFD · DE
• Decision Date: Jan 4, 2013
• Decision: SESE
• Submission Type: Special
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

The biotene Oral Balance Gel, biotene Dry Mouth Oral Rinse and biotene Moisturizing Mouth Spray intended use is to relieve the symptoms of dry mouth, refresh, moisturize, clean, soothe oral irritation and lubricate oral dryness.

Device Story

Biotene Oral Balance Gel, Dry Mouth Oral Rinse, and Moisturizing Mouth Spray are artificial saliva products designed to manage xerostomia. These products are applied topically within the oral cavity to provide moisture, lubrication, and soothing relief for oral dryness and irritation. They are intended for over-the-counter use by patients experiencing dry mouth symptoms. The devices function by coating the oral mucosa to mimic natural saliva properties, thereby improving patient comfort and oral hygiene. No complex electronic or algorithmic components are involved.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Artificial saliva formulation; topical gel, rinse, and spray delivery forms. Non-electronic, non-software, non-implantable. Compositional characteristics consistent with standard oral care products for xerostomia management.

Indications for Use

Indicated for individuals experiencing symptoms of dry mouth (xerostomia) to provide relief, refreshment, moisturization, cleaning, soothing of oral irritation, and lubrication of oral dryness.

Submission Summary (Full Text)

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

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#### Public Health Service

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

### January 4, 2013

Mr. Paul Krumm Regulatory Affairs Manager GlaxoSmithKline Consumer Healthcare (GSKCH) 1500 Littleton Road PARSIPPANY NJ 07054

Re: K123731

Trade/Device Name: Biotene Oral Balance Gel, Biotene Dry Mouth Oral Rinse, Biotene Moisturizing Mouth Spray

Regulation Number: Unclassified Regulation Name: Saliva, Artificial Regulatory Class: Unclassified Product Code: LFD Dated: December 4, 2012 Received: December 10, 2012

#### Dear Mr. Krumm:

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 - Mr. Krumm

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 of medical devicerelated 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,

Anthony De m

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use Statement

510(k) Number (If known):

Devices Names: biotene Oral Balance Gel, biotene Dry Mouth Oral Rinse, biotene Moisturizing Mouth Spray

Indications for Use: The biotene Oral Balance Gel, biotene Dry Mouth Oral Rinse and biotene Moisturizing Mouth Spray intended use is to relieve the symptoms of dry mouth, refresh, moisturize, clean, soothe oral irritation and lubricate oral dryness.

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### Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

AND/OR

Over-The-Counter Use

2013.01.04 Susan Runner DDS, MA 12:41:11 -05'00'

(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital
Division of Anesthesiology, General Devices Division of Ancounters

**510(k) Number:** K12373

Biotene Artificial Saliva Products Modifications

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