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Pulpdent Fluoride Varnish is a resin-based 5% sodium fluoride varnish, formulated without volatile solvents, that is applied to enamel or dentin and is used for professional treatment of dental hypersensitivity by occluding dentinal tubules and by promoting an environment conducive to remineralization.

Pulpdent Fluoride Varnish is a resin-based 5% sodium fluoride varnish, formulated without volatile solvents, that is applied to enamel or dentin and is used for professional treatment of dental hypersensitivity by occluding dentinal tubules and by promoting an environment conducive to remineralization.

This 510(k) premarket notification for Pulpdent Fluoride Varnish does not contain a study that establishes acceptance criteria and then demonstrates the device meets those criteria through performance testing.

Instead, the submission relies on the concept of substantial equivalence to predicate devices that have been on the market for an extended period with a history of safe and effective use.

Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, ground truth, and expert involvement is not applicable to this specific submission.

Here's an breakdown of the available information based on your request, highlighting what is not present:

1. Table of Acceptance Criteria and Reported Device Performance

Not Applicable.

This submission does not define specific acceptance criteria (e.g., a required percentage reduction in hypersensitivity, or a specific level of remineralization) for Pulpdent Fluoride Varnish, nor does it present device performance data against such criteria.

The basis for regulatory clearance is "substantial equivalence" to predicate devices, implying that its performance is expected to be similar to devices already found safe and effective. The submission states: "Pulpdent Fluoride Varnish is substantially equivalent in design, composition, performance, intended use, safety and effectiveness to the predicate products listed above."

2. Sample Size Used for the Test Set and Data Provenance

Not Applicable.

No specific test set or associated sample size is described for this device's performance evaluation. The safety and effectiveness claim is based on the long-term market history of the predicate devices.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not Applicable.

No specific ground truth establishment for a test set is described.

4. Adjudication Method for the Test Set

Not Applicable.

No test set or adjudication method is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

Not Applicable.

No MRMC comparative effectiveness study was performed or referenced for this device. The device is a physical product (fluoride varnish), not an AI or imaging diagnostic tool where such studies are typically relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not Applicable.

This is a physical medical device (fluoride varnish), not an algorithm or software. Standalone performance as typically understood in AI/software evaluations is not relevant here.

7. The Type of Ground Truth Used

Indirect Ground Truth: Clinical history of predicate devices.

The "ground truth" for the claim of safety and effectiveness is the established safety and effectiveness profile of the predicate devices, which have been "on the market and used successfully by dental professionals for more than 15 years with no serious safety or effectiveness problems." This relies on real-world clinical outcomes over an extended period.

8. The Sample Size for the Training Set

Not Applicable.

No "training set" in the context of algorithm development is relevant to this physical device.

9. How the Ground Truth for the Training Set Was Established

Not Applicable.

No training set or associated ground truth establishment is relevant to this physical device.

Summary of the K093620 Submission Strategy:

The manufacturer, Pulpdent Corporation, opted for a 510(k) Premarket Notification based on substantial equivalence. This pathway allows devices to be cleared for market if they are shown to be as safe and effective as a legally marketed predicate device. In this case, the safety and effectiveness of Pulpdent Fluoride Varnish is primarily supported by:

• Comparison to Predicate Products: Pulpdent Fluoride Varnish is stated to be "substantially equivalent in design, composition, performance, intended use, safety and effectiveness" to several fluoride varnishes already on the market (e.g., Scientific Pharmaceuticals Sci-Pharm Desensitizing Varnish, Ultradent Flor-Opal Varnish White, 3M Vanish 5% NaF White Varnish, Colgate Duraphat).
• Long-term Market History of Predicates: The predicate products have a history of "more than 15 years" of successful use by dental professionals "with no serious safety or effectiveness problems."
• Compositional Similarity: The device is formulated with materials "that have been used in the dental industry for many years without incident."
• Literature References: A list of 16 scientific articles related to the safety and effectiveness of fluoride varnishes in general is provided, further supporting the understanding of the class of devices. These references likely contribute to the general understanding of fluoride varnish efficacy in treating dental hypersensitivity and promoting remineralization, implicitly supporting the claim for the new device as well.

This approach bypasses the need for new clinical trials or detailed performance studies for the specific device if substantial equivalence can be adequately demonstrated.

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