K Number
K040236
Date Cleared
2004-04-20

(78 days)

Product Code
Regulation Number
872.3275
Panel
DE
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Pulpdent VLC Resin Coment is a fluoride releasing, visible light-cure dental resin rement that contains no Bisphenol A. It is used to permanently cement ceramic coment that contains no crowns, inlays, onlays, bridges, bridges, veneers, and periodontal splints to tooth structure.

Device Description

PULPDENT VLC Resin Cement is a fluoride-releasing, visible light cure dental resin cement that contains no Bisphenol A.

AI/ML Overview

The provided document is a 510(k) premarket notification for a dental cement, PULPDENT VLC RESIN CEMENT, from 2004. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed clinical study data with specific acceptance criteria and performance metrics in the way a medical device approval for a novel AI algorithm might.

Therefore, much of the requested information regarding acceptance criteria, specific performance metrics, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, or standalone performance, is not present in this document. This is typical for a 510(k) for a dental material like cement, where substantial equivalence is often based on material properties, intended use, and a history of safe use of similar materials.

Here's what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Implied by 510(k) process)Reported Device Performance (as stated in the document)
Substantial equivalence in design, composition, performance, intended use, safety, and effectiveness to predicate devices."PULPDENT VLC Resin Cement is substantially equivalent in design, composition, performance, intended use, safety and effectiveness to the predicate products listed above."
Safe operation."General usage of these materials over about 20 years indicates a high benefit-to-risk ratio...both composites and glass ionomers are relatively trouble-free. There is no evidence of short-term or long-term risk...There is no suspicion of any problems after virtually billions of procedures in the United States." (Referring to the class of materials, not specifically the device's performance, but implying safety based on historical use).
Effectiveness for stated indications.Intended Use: "permanently cement ceramic restorations, such as Cerec, porcelain crowns, inlays, onlays, bridges, veneers and periodontal splints to tooth structure."
No Bisphenol A."contains no Bisphenol A."
Fluoride-releasing."is a fluoride-releasing"
Visible light cure."visible light-cure dental resin cement"

2. Sample size used for the test set and the data provenance

  • Not Applicable / Not Provided. The document does not describe a "test set" in the context of clinical performance evaluation with a specified sample size. Substantial equivalence for this type of device is typically based on material property testing, biocompatibility, and comparison to existing products, rather than a clinical trial with a "test set" of patients.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

  • Not Applicable / Not Provided. This information is for clinical and AI device evaluations, not relevant for this 510(k) submission of a dental cement.

4. Adjudication method for the test set

  • Not Applicable / Not Provided. No "adjudication method" for a test set is described.

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 Provided. This document is for a dental cement, not an AI-assisted diagnostic device, so an MRMC study is not relevant.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

  • Not Applicable / Not Provided. This document is for a dental cement, not an algorithm, so standalone performance is not relevant.

7. The type of ground truth used

  • Not Applicable / Not Provided. The concept of "ground truth" as it applies to clinical data for diagnostic performance is not relevant here. The "truth" for this device lies in its material properties, biocompatibility, and successful adhesion/retention as a dental cement, which are assessed through laboratory testing and predicate comparison, not clinical outcome "ground truth" derived from patient data in the context of diagnosis.

8. The sample size for the training set

  • Not Applicable / Not Provided. This device is a material, not an AI algorithm, so there is no training set.

9. How the ground truth for the training set was established

  • Not Applicable / Not Provided. As there is no training set, this question is not applicable.

§ 872.3275 Dental cement.

(a)
Zinc oxide-eugenol —(1)Identification. Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class II.