(128 days)
Not Found
No
The summary describes a topical oral product with lubricating and moisturizing properties, similar to existing artificial saliva substitutes. There is no mention of AI, ML, image processing, or data sets typically associated with AI/ML technologies.
Yes
The device is intended to alleviate symptoms of dry mouth (xerostemia) caused by various medical conditions or treatments, which is a therapeutic purpose.
No
The device is described as an artificial saliva substitute that alleviates symptoms of dry mouth, not as a tool to diagnose a condition or disease.
No
The device description clearly states it is a gel, liquid, or spray, which are physical substances, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a product applied directly to the oral cavity to alleviate symptoms of dry mouth. This is a therapeutic or symptomatic relief function, not a diagnostic one.
- Device Description: The description explicitly states it's an "artificial saliva substitute" with lubricating, neutralizing, and moistening properties. This aligns with a product for managing symptoms, not for diagnosing a condition.
- Lack of Diagnostic Elements: There is no mention of the device being used to test samples (like saliva, blood, etc.) to determine the presence of a disease, condition, or physiological state.
- Predicate Devices: The listed predicate devices (Oral Balance Gel and Liquid, Caphasol, Salivart, Salinum or Oraclair, TGO Spray) are all products intended for the symptomatic relief of dry mouth, not for diagnosis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
LFD
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Oral Cavity
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)
Functional and performance evaluation has been conducted to assess the safety and effectiveness of Oral Neutralizer liquid, gel, and spray. All results are satisfactory.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K061331, K991938, K981693, K024148, K051812
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
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 |
| Albany OR 97321 | |
| c. Submitter Telephone: | |
| d. Submitter Facsimile: | (541)928-4445 |
| (541)928-2444 | |
| e. Contact Person: | Bob Bowers |
| 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 |
1
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
Neutralizer | Oral
Balance | TGO Spray | Caphesol | Salivart | Salinum/Oraclair |
|-------------------------|-------------------------------------------|-------------------------------------------|-------------------------------------------|-------------------------------------------|-------------------------------------------|-------------------------------------------|
| Intended Use | Symptomatic
Treatment of
Xerostomia | Symptomatic
Treatment of
Xerostomia | Symptomatic
Treatment of
Xerostomia | Symptomatic
Treatment of
Xerostomia | Symptomatic
Treatment of
Xerostomia | Symptomatic
Treatment of
Xerostomia |
| Method of Use | Ready to use
liquid, gel,
spray | Ready to
use Liquid
and gel | Ready to
use spray | Mix parts
A&B
ampoules | Ready to
use spray | Ready to use
liquid/rinse |
| Applications per
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.
2
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.
3
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 (240) 276-0115. 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 (800) 638-2041 or (301) 443-6597 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
4
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