(123 days)
Not Found
No
The device description and performance studies focus on the physical and chemical properties of a fluoride varnish, with no mention of AI or ML.
No
The device is described as treating symptoms (tooth hypersensitivity) by occluding dentinal tubules, rather than treating or preventing a disease or condition. This aligns with the definition of a palliative or supportive device, which is not considered a therapeutic device.
No
Explanation: The device is a varnish used for professional treatment of dental hypersensitivity by forming a film on tooth surfaces. It is a treatment device, not a diagnostic one.
No
The device is a physical product (fluoride varnish) applied to teeth, not a software program.
Based on the provided information, ProFluoro™ Fluoride Varnish is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "Professional treatment of dental hypersensitivity by occluding dentinal tubules with an adherent film." This describes a therapeutic treatment applied directly to the patient's teeth, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description details a substance applied to tooth surfaces, which then cures with saliva. This is a topical application for treatment, not a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of analyzing a sample (like blood, urine, or tissue), detecting biomarkers, or providing information for diagnosis.
IVDs are devices used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. ProFluoro™ Fluoride Varnish does not fit this definition.
N/A
Intended Use / Indications for Use
ProFluoro™ Fluoride Varnish is intended for use as:
- Professional treatment of dental hypersensitivity by occluding dentinal tubules with an adherent film
Product codes
LBH
Device Description
ProFluoro™ Fluoride Varnish is a resin-based 5% sodium fluoride varnish applied to tooth surfaces with an applicator brush. Moisture from saliva cures the varnish and leaves a film on tooth to treat tooth hypersensitivity.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tooth surfaces
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Professional
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)
This 510(k) submission includes data from bench testing to evaluate the performance of ProFluoro™ Fluoride Varnish compared to predicate device Enamelast™ Fluoride Varnish. Properties evaluated include appearance, total fluoride (wt%), pH and film thickness. It was concluded that ProFluoro™ Fluoride Varnish is substantially equivalent to and in some cases exceeding the predicate device in terms of physical properties.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Enamelast™ Fluoride Varnish (K132109)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3260 Cavity varnish.
(a)
Identification. Cavity varnish is a device that consists of a compound intended to coat a prepared cavity of a tooth before insertion of restorative materials. The device is intended to prevent penetration of restorative materials, such as amalgam, into the dentinal tissue.(b)
Classification. Class II (special controls). The device, when it is an external cleaning solution, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.
0
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 stylized eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 30, 2014
Pac-Dent International, Inc. Ms. Wenying Zhu Materials Engineer 21038 Commerce Point Drive Walnut, CA 91789
Re: K141422
Trade/Device Name: ProFluro™ Fluoride Varnish Regulation Number: 21 CFR 872.3260 Regulation Name: Cavity Varnish Regulatory Class: II Product Codes: LBH Dated: June 30, 2014 Received: July 9, 2014
Dear Ms. Zhu:
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 – Ms. Zhu
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Image /page/1/Picture/5 description: The image shows the text "Mary S. Runner -S" in a simple, sans-serif font. The text is arranged horizontally, with the name "Mary S. Runner" followed by a hyphen and the letter "S". The text is clear and legible, and the overall impression is clean and straightforward. The text is likely a name or a title.
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Image /page/2/Picture/0 description: The image is a logo for PacDent International, Inc. The logo is set against an orange background. The words "PacDent" are in a bold, sans-serif font, with a curved line underneath. Below "PacDent" is the text "International, Inc." and "passion for excellence..." in a smaller font.
Pac-Dent International, Inc. 21038 Commerce Pointe Dr. Walnut = California = 91789
t: 909.839.0888 f: 909.839.0881 www.pac-dent.com
Section III
Indications for Use Statement
K141422 510(k) Number (if known):
Device Name: _ ProFluoro™ Fluoride Varnish
Indications for Use:
ProFluoro™ Fluoride Varnish is intended for use as:
- Professional treatment of dental hypersensitivity by occluding dentinal tubules with an adherent film
Prescription Use _______________
OR
Over-The-Counter Use __
3
Image /page/3/Picture/0 description: The image is a logo for PacDent International, Inc. The logo is set against an orange background. The words "PacDent" are in bold, black letters, with a registered trademark symbol next to it. Below that, the words "International, Inc." are in a smaller font, and below that, the words "passion for excellence..." are in a smaller font.
Pac-Dent International, Inc.
21038 Commerce Pointe Dr. Walnut = California = 91789
t: 909.839.0888 f: 909.839.0881 www.pac-dent.com
Section IV
510(k) Summary
Submitter:
Pac-Dent International, Inc. 21038 Commerce Point Dr. Walnut, CA91789
Contact Person:
Wenying Zhu Materials Engineer 909-839-0888 ext.111
Date Summary Prepared:
May 2014
Device Name Trade Name: ProFluoro™ Fluoride Varnish Common Name: Cavity varnish Device Classification: Class II Classification Product Code: LBH Classification Name: Cavity varnish, per 21 CFR 872.3260
Predicate Device
Enamelast™ Fluoride Varnish (K132109)
Description of Device
ProFluoro™ Fluoride Varnish is a resin-based 5% sodium fluoride varnish applied to tooth surfaces with an applicator brush. Moisture from saliva cures the varnish and leaves a film on tooth to treat tooth hypersensitivity.
Indications for Use
- Professional treatment of dental hypersensitivity by occluding dentinal tubules with an ●
4
Image /page/4/Picture/0 description: The image is a logo for PacDent International, Inc. The logo is set against an orange background. The words "PacDent" are in large, bold, black font, with a registered trademark symbol to the right. Below this, the words "International, Inc." are in a smaller font, and below that, the words "passion for excellence..." are in a smaller, italicized font.
Pac-Dent International, Inc. 21038 Commerce Pointe Dr. Walnut = California = 91789
t: 909.839.0888 f: 909.839.0881 www.pac-dent.com
adherent film
Summary of Biocompatibility Tests
The chemical components in ProFluoro™ Fluoride Varnish have been used in predicate device. Rosin and other rosin derivatives are used as adhesive agents in FDA approved dental varnishes. These include Duraflor®, Vanish "" Varnish, Enamel Pro® Varnish, Enamelast™ and the other fluoride varnishes. We believe these facts well support the compatibility of ProFluoro'™ Fluoride Varnish, and the safety of the applicant device is substantially equivalent to the predicate devices in materials and technological properties.
The risk analysis provided above also shows that ProFluoro™ Fluoride Varnish is safe for its intended use.
No biocompatibility test is required to establish substantial equivalent to the predicate device.
Summary of Physical Tests
This 510(k) submission includes data from bench testing to evaluate the performance of ProFluoro™ Fluoride Varnish compared to predicate device Enamelast™ Fluoride Varnish. Properties evaluated include appearance, total fluoride (wt%), pH and film thickness. It was concluded that ProFluoro™ Fluoride Varnish is substantially equivalent to and in some cases exceeding the predicate device in terms of physical properties.
Substantial Equivalence
In summary, this submission demonstrates that ProFluoro™ Fluoride Varnish is substantially equivalent in safety and effectiveness and performs equivalently or better to the identified predicated and comparable product for its intended use.