(84 days)
Intended for: 1) treatment of hypersensitive teeth: 2) sealing the dentinal tubu es for cavity preparations or on sensitive root surfaces; and 3) a cavity liner.
FLUORIDE VARNISH coats a prepared tooth surface prior to placement of any restorative materials to prevent any of the restorative materials from pene rating into the dentinal tissue. FLUORIDE VARNISH contains releasable fluoride.
FLUORIDE VARNISH will be offered in unit dose vials with applicator brushes. Each vial contins material to treat 4-8 teeth, depending on their size.
This document is a 510(k) Summary for a medical device called "FLUORIDE VARNISH." It is a regulatory filing with the FDA, primarily focused on establishing substantial equivalence to previously marketed devices.
Based on the provided document, the device described is a Fluoride Varnish intended for dental use. The document focuses on regulatory approval based on substantial equivalence, not a study proving specific performance metrics against pre-defined acceptance criteria in the way an AI/ML device would.
Therefore, many of the requested elements (acceptance criteria, device performance table, sample sizes, expert ground truth, adjudication, MRMC, standalone performance, training set details) are not applicable or not present in this type of regulatory submission. This document aims to demonstrate that the new device is as safe and effective as existing legally marketed predicate devices, primarily through its components, intended use, and biocompatibility, not through a clinical performance study with quantitative acceptance criteria for predictive accuracy.
Here's an analysis of the available information:
1. A table of acceptance criteria and the reported device performance
Not applicable/Not present. This document is a 510(k) summary for a dental varnish, establishing substantial equivalence based on composition and intended use, not on quantitative performance metrics requiring specific acceptance criteria like an AI/ML diagnostic device.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable/Not present. This document does not describe a clinical performance study with a test set in the context of device performance metrics. Instead, it references biocompatibility testing and the prior use of components in legally marketed devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable/Not present. This is not a diagnostic device requiring expert-established ground truth for performance evaluation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable/Not present.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable/Not present. This document does not describe an AI/ML device or a comparative effectiveness study involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable/Not present. This is not an algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The concept of "ground truth" as typically applied to diagnostic performance studies is not directly relevant here. The "truth" in this context refers to the safety and effectiveness of the device based on its components, manufacturing, and intended use being comparable to predicate devices. The document states:
- "All of the components found in FLUORIDE VARNISH have been used in legally marketed devices or were found safe for dental use."
- "FLUORIDE VARNISH has been evaluated and passed biocompatibility testing for cytotoxicity, acute oral toxicity, irritation, and sensitization."
This suggests that the "ground truth" for proving safety and effectiveness relies on:
- Historical data and prior regulatory approvals of the individual components.
- Biocompatibility testing results (which serve as the "ground truth" for the device's biological safety).
8. The sample size for the training set
Not applicable/Not present. This is not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established
Not applicable/Not present.
Summary of Device and Approval Process from the Document:
- Device Name: FLUORIDE VARNISH
- Manufacturer: DENTSPLY International
- Intended Use:
- Treatment of hypersensitive teeth
- Sealing the dentinal tubules for cavity preparations or on sensitive root surfaces
- A cavity liner
- Predicate Devices: Duraphat Fluoride Varnish (K945794) and Duragard Fluoride Varnish (K002581)
- Approval Basis: Substantial equivalence to predicate devices, based on:
- Shared components with legally marketed devices.
- Biocompatibility testing (cytotoxicity, acute oral toxicity, irritation, sensitization).
- Performance data (though not detailed as quantitative metrics in this summary).
- Regulatory Decision: FDA determined the device is substantially equivalent to legally marketed predicate devices.
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SEP 1 5 2003
510(k) SUMMARY
DENTSPLY
NAME & ADDRESS:
NTSPLY Internationa 70 West College Avenue .O. Box 872 York, PA 17405-0872 717| 845-7511 ww.dentsplv.com
Ko 31932
P. J. Lehn Telefax (717) 849-4343
| CONTACT: | P. Jeffery Lehn | |
|---|---|---|
| DATE PREPARED: | June 19, 2003 | |
| TRADE OR PROPRIETARY NAME: | FLUORIDE VARNISH | |
| CLASSIFICATION NAME: | Cavity Varnish | 872.3260 |
| PRE DICATE DEVICES: | Duraphat Fluoride Varnish | K945794 |
| Duragard Fluoride Varnish | K002581 |
DEVICE DESCRIPTION: FLUORIDE VARNISH coats a prepared tooth surface prior to placement of any restorative materials to prevent any of the restorative materials from pene rating into the dentinal tissue. FLUORIDE VARNISH contains releasable fluoride.
FLUORIDE VARNISH will be offered in unit dose vials with applicator brushes. Each vial contins material to treat 4-8 teeth, depending on their size.
INTENDED USE: Intended for: 1) treatment of hypersensitive teeth: 2) sealing the dentinal tubu es for cavity preparations or on sensitive root surfaces; and 3) a cavity liner.
TECHNOLOGICAL CHARACTERISTICS: All of the components found in FLUORIDE VAF NISH have been used in legally marketed devices or were found safe for dental use.
FLUORIDE VARNISH has been evaluated and passed biocompatibility testing for cytotoxicity, acut : oral toxicity, irritation, and sensitization.
We selieve that the prior use of the components of FLUORIDE VARNISH in legally marketed predicate devices, the performance data provided, and the biocompatibility data provided support the safety and effectiveness of FLUORIDE VARNISH for the indicated uses.
11 - 12.04
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Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.
Public Health Service
SEP 1 5 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. P. Jeffery Lehn Director of Corporate Compliance and Regulatory Affairs Dentsply International 570 West College Avenue P.O. Box 872 York, Pennsylvania 17405-0872
Re: K031932
Trade/Device Name: Fluoride Varnish Regulation Number: 872.3260 Regulation Name: Cavity Varnish Regulatory Class: II Product Code: LBH Dated: June 19, 2003 . Received: June 23, 2003
Dear Mr. Lehn:
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.
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Page 2 - Mr. Lehn
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); 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 (301) 594-4613. 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/dsma/dsmamain.html
Sincerely yours,
Susan Runner
Susan Runner, DDS, MA Interim 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 STATEMENT
(As Required by 21 CFR 807.87(e)
510(K) Number (if known): 4503 (932
FLUORIDE VARNISH Device Name:
Indications for Use:
- Treatment of hypersensitive teeth e
- () Sealing of dentinal tubules for cavity preparations or on sensitive root surfaces
- Cavity liner t)
Kein Mulay for MSA
on of Anesthesiology. General Hospital, Infection Control, Dental Devices
510(k) Number:_
(PI.EASE: DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
I rescription Use
OR
Over-The-Counter Use
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
§ 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.