(123 days)
ProFluoro™ Fluoride Varnish is intended for use as:
- Professional treatment of dental hypersensitivity by occluding dentinal tubules with an adherent film
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.
This document describes a 510(k) premarket notification for "ProFluoro™ Fluoride Varnish" by Pac-Dent International, Inc. The purpose of the submission is to demonstrate substantial equivalence to legally marketed predicate devices.
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Property) | Predicate Device (Enamelast™ Fluoride Varnish) Performance | ProFluoro™ Fluoride Varnish Performance |
|---|---|---|
| Appearance | Not explicitly stated beyond being a fluoride varnish, implied to be acceptable for its intended use. | Implied to be acceptable and comparable to predicate. |
| Total Fluoride (wt%) | Not explicitly stated, but implied to be within acceptable range for a 5% sodium fluoride varnish. | Measured and compared to predicate device. Implied to be equivalent or better. |
| pH | Not explicitly stated, but implied to be within acceptable range. | Measured and compared to predicate device. Implied to be equivalent or better. |
| Film thickness | Not explicitly stated, but implied to be within acceptable range. | Measured and compared to predicate device. Implied to be equivalent or better. |
| Biocompatibility | Established based on predicate devices using similar chemical components. | Established based on the use of similar chemical components as predicate devices (Rosin and other rosin derivatives). Risk analysis also supports safety. No additional biocompatibility testing was deemed required. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated for each specific physical test (appearance, total fluoride, pH, film thickness). The document refers to "bench testing" without providing specific sample numbers for each measurement.
- Data Provenance: The study was conducted as "bench testing," meaning it was performed in a laboratory setting. The country of origin for the data is not specified, but the applicant (Pac-Dent International, Inc.) is based in Walnut, CA, USA, suggesting the testing was likely conducted in the USA or supervised by the US-based company. The study is retrospective in the sense that it evaluates the performance of the new device against an existing predicate.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable to this type of submission. The "ground truth" for the physical and chemical properties of a fluoride varnish is based on established scientific and engineering principles and objective measurements, not expert consensus in the diagnostic sense. The comparison is against quantifiable properties of a predicate device.
4. Adjudication method for the test set:
Not applicable. This study focuses on objective physical and chemical property comparisons rather than subjective human assessments requiring adjudication.
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. This submission concerns a fluoride varnish, not an AI-powered diagnostic device. Therefore, no MRMC study or AI-assistance evaluation was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This submission concerns a fluoride varnish, not an algorithm or AI device.
7. The type of ground truth used:
The ground truth for the physical tests (appearance, total fluoride, pH, film thickness) was the measured performance of the legally marketed predicate device, Enamelast™ Fluoride Varnish, combined with established scientific standards for such dental materials. For biocompatibility, the ground truth was the established safety record of the chemical components when used in predicate devices and the results of a risk analysis.
8. The sample size for the training set:
Not applicable. As this is not an AI/machine learning device, there is no concept of a "training set."
9. How the ground truth for the training set was established:
Not applicable. See point 8.
§ 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.