AIR LIFT/XEROSTOM ARTIFICIAL SALIVA

K120552 · Biocosmetics Laboratories · LFD · Jun 6, 2012 · DE

Device Facts

• Record ID: K120552
• Device Name: AIR LIFT/XEROSTOM ARTIFICIAL SALIVA
• Applicant: Biocosmetics Laboratories
• Product Code: LFD · DE
• Decision Date: Jun 6, 2012
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

Formulated for the relief of dry mouth symptoms such as difficulties in swallowing, speech, changes in taste, mouth discomfort, mouth odors and bad breath, and other symptoms associated with dry mouth. These symptoms may be brought on by disease, stress, aging or medication. May be used to replace normal saliva, when salivary glands are damaged or not functioning. - Relieves the Problems of Dry Mouth . - Relieving dry mouth may be effective against oral halitosis and bad breath .

Device Story

Air-Lift/Xerostom is a topical oral product designed to alleviate symptoms of xerostomia (dry mouth). It functions as a saliva substitute to provide moisture and relief from discomfort, swallowing difficulties, and halitosis associated with salivary gland dysfunction. The device is intended for use by patients suffering from dry mouth due to various etiologies, including medication side effects, aging, or disease. It is applied topically within the oral cavity to mimic natural saliva function.

Indications for Use

Indicated for patients experiencing dry mouth symptoms (xerostomia) caused by disease, stress, aging, or medication, including those with damaged or non-functioning salivary glands. Used to relieve swallowing difficulties, speech impairment, taste changes, mouth discomfort, and halitosis.

Submission Summary (Full Text)

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

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

Biocosmetics Laboratories C/O Mr. Ray Kelly 57 Lazy Brook Road Monroe, Connecticut 06468

JUN - 6 2012

Re: K120552

Trade/Device Names: Air-Lift/Xerostom Regulation Number: None Regulation Name: None Regulatory Class: unclassified Product Code: LFD Dated: May 29, 2012 Received: May 30, 2012

Dear Mr. Kelly:

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. Kelly:

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,

hi for

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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# INDICATIONS FOR USE

510(k) Number (if known): K120552

Device Name: Air-Lift/Xerostom

Indications for Use:

Formulated for the relief of dry mouth symptoms such as difficulties in swallowing, speech, changes in taste, mouth discomfort, mouth odors and bad breath, and other symptoms associated with dry mouth. These symptoms may be brought on by disease, stress, aging or medication.

May be used to replace normal saliva, when salivary glands are damaged or not functioning.

- Relieves the Problems of Dry Mouth .
- Relieving dry mouth may be effective against oral halitosis and bad breath .

Prescription Use V (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)

Suor Rumo

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

510(k) Number: k120552