(503 days)
Not Found
No
The device description and performance studies focus on the chemical composition and biocompatibility of a dental varnish, with no mention of AI or ML technology.
Yes
The device is described as a "desensitizing agent used for sealing of dentinal tubules for the treatment of hypersensitive teeth, sensitive root surfaces and for cavity preparation," which indicates its use in treating medical conditions.
No
The device is described as a "desensitizing agent" for treatment of hypersensitive teeth and sensitive root surfaces, which indicates a therapeutic rather than diagnostic function. Its intended use focuses on sealing dentinal tubules and treating sensitivity, not identifying or characterizing a condition.
No
The device description clearly indicates it is a desensitizing agent (a substance applied to teeth) and a varnish, which are physical materials, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses listed are for the treatment of conditions related to teeth (dentinal hypersensitivity, exposed cervicals, sensitivity after tooth whitening). This is a therapeutic application, not a diagnostic one.
- Device Description: The device is described as a "desensitizing agent used for sealing of dentinal tubules." This is a material applied to the body for a therapeutic effect.
- Lack of Diagnostic Elements: There is no mention of the device being used to analyze samples from the body (like blood, urine, tissue) to provide information about a patient's health status, which is the core function of an IVD.
- Performance Studies: The performance studies focus on biocompatibility and material standards (ISO 1641, ISO 10993), which are relevant for therapeutic devices, not typically for IVDs.
In summary, the device's function is to treat a condition by applying a material to the teeth, which falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
- Treatment of dentinal hypersensitivity
- Treatment of exposed cervicals
- Treatment of sensitivity after tooth whitening
Product codes
LBH
Device Description
Fluor Protector S is a desensitizing agent used for sealing of dentinal tubules for the treatment of hypersensitive teeth, sensitive root surfaces and for cavity preparation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
dentinal tubules, teeth, root surfaces
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)
The device was tested in accordance with ISO 1641:2009 Dentistry - Medical devices for dentistry - Materials. Biocompatibility testing and evaluation was also carried out according to ISO 10993 where the following tests were conducted on the subject device and the predicate device: Cytotoxicity, genotoxicity, sensitization, oral irritation, Acute systemic toxicity. All results show favorable biocompatibility for the subject device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Fluor Protector (K946032)
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a human figure in profile, with three overlapping faces suggesting community and support.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 8, 2014
Ivoclar Vivadent, Incorporated Ms. Donna Hartnett Director OA/Regulatory Affairs 175 Pineview Drive Amherst, NY 14228
Re: K131487
Trade/Device Name: Fluor Protector S Regulation Number: 21 CFR 872.3260 Regulation Name: Cavity Varnish Regulatory Class: II Product Code: LBH Dated: September 3, 2014 Received: September 4, 2014
Dear Ms. Hartnett:
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 - Ms. Hartnett
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/Resourcesfor You/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,
Susan Runno DDS, MA
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
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Indications for Use
510(k) Number (if known):
K131487
Device Name: Fluor Protector S
Indications For Use:
-
Treatment of dentinal hypersensitivity
-
Treatment of exposed cervicals
-
Treatment of sensitivity after tooth whitening
Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of 1
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510(K) SUMMARY
Fluor Protector S
Revised October 7, 2014
| Contact: | Donna Marie Hartnett |
|---|---|
| Company: | Ivoclar Vivadent. 175 Pineview Drive, Amherst, NY 14228 |
| (716) 691-0010 | |
| Date Prepared: | |
| Proprietary Name: | Fluor Protector S |
| Classification Name: | Cavity Varnish (872.3260) |
| Predicate Devices: | Fluor Protector (K946032) |
Device Description: Fluor Protector S is a desensitizing agent used for sealing of dentinal tubules for the treatment of hypersensitive teeth, sensitive root surfaces and for cavity preparation.
The predicate device to which Fluor Protector S has been compared is Fluor Protector (K946032). For this application, Fluor Protector S has been compared to its predicate with regard to chemical composition, performance data and indications for use. The primary difference between the subject device and the predicate device is the use of Ammonium fluoride in the subject de vice. Even though there is an approximately 8-fold difference in fluoride content in solution between the subject device and the predicate device, the difference is only 3.6-fold in the dry varnish, which is the "active state" of the device. Apart from fluoride content, the varnishes are very similar (low viscosity, clear, transparent, multi- and single dose). The comparison shows that Fluor Protector S is substantially equivalent to the predicate device.
Intended Use:
- Treatment of dentinal hypersensitivity
- Treatment of exposed cervicals
- Treatment of sensitivity after tooth whitening
Technological Characteristics: The device design, i.e. delivery form, and intended use of Fluor Protector S and the predicate device are the same. The composition of the subject device has been modified from the predicate, however, there are no ingredients in the subject device which pose any new issues of safety and effectiveness.
Testing Summary: The device was tested in accordance with ISO 1641:2009 Dentistry - Medical devices for dentistry - Materials. Biocompatibility testing and evaluation was also carried out according to ISO 10993 where the following tests were conducted on the subject device and the predicate device: Cytotoxicity, genotoxicity, sensitization, oral irritation, Acute systemic toxicity. All results show favorable biocompatibility for the subject device.
Conclusion: Fluor Protector S is substantially equivalent to the predicate device.