(30 days)
Not Found
Not Found
No
The summary describes a gel, rinse, and spray for dry mouth relief, with no mention of AI or ML technology.
No
The device is intended to relieve symptoms and provide comfort for dry mouth, rather than treat a disease or condition. This aligns with cosmetic or general health products under FDA regulations, not therapeutic devices.
No
The intended use states the device is to "relieve the symptoms of dry mouth, refresh, moisturize, clean, soothe oral irritation and lubricate oral dryness," which describes symptom relief and comfort, not diagnosis.
No
The 510(k) summary describes oral care products (gel, rinse, spray) which are physical substances, not software.
Based on the provided information, the biotene Oral Balance Gel, biotene Dry Mouth Oral Rinse, and biotene Moisturizing Mouth Spray are not IVDs (In Vitro Diagnostics).
Here's why:
- Intended Use: The intended use is to relieve symptoms of dry mouth, refresh, moisturize, clean, soothe oral irritation, and lubricate oral dryness. This describes a product applied to the body (specifically the oral cavity) for symptomatic relief and comfort.
- Lack of Diagnostic Purpose: There is no mention of the product being used to diagnose, monitor, or screen for any disease or condition by examining samples from the body (like blood, urine, tissue, etc.).
- Over-The-Counter Use: The intended user is for over-the-counter use, which is typical for personal care or symptomatic relief products, not diagnostic devices that often require professional interpretation.
- Anatomical Site: The anatomical site is "oral," indicating application to the mouth, not analysis of samples taken from the body.
IVDs are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or screening of diseases or conditions. The provided description clearly indicates a product for topical application and symptomatic relief within the oral cavity.
N/A
Intended Use / 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.
Product codes
LFD
Device Description
biotene Oral Balance Gel, Biotene Dry Mouth Oral Rinse, Biotene Moisturizing Mouth Spray
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight.
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.
1
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 (800) 638-2041 or (301) 796-7100 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
2
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.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
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
Volume 1 Page 34 of 52