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K Number
K993514
Device Name
DEFINITE
Manufacturer
DEGUSSA - NEY DENTAL, INC.
Date Cleared
2000-02-24

(129 days)

Product Code
EBF
Regulation Number
872.3690
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Definite® is a light cured composite intended to be used for all classes of restorations from class I to class V.

Device Description

Definite® is a light cured composite offered as a single paste system in compules. The system consists of the filling material Definite® and the self etching adhesive Etch&Prime® 3.0.

AI/ML Overview

The provided FDA document (K993514) is a 510(k) clearance letter for a dental restorative material called "Definite®". It is a premarket notification, not a clinical study report. Therefore, it does not contain any information about acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies.

The document only states that the device is "substantially equivalent" to legally marketed predicate devices for use in "all classes of restorations from class I to class V." This substantial equivalence determination is based on the comparison to predicate devices, not on a new clinical study detailed in this specific document.

To answer the requested questions, one would need access to the full 510(k) submission, which is typically not publicly available in this level of detail, or reference a separate clinical study report, if one was conducted and made public.

Therefore, based solely on the provided document, I cannot provide information for the following:

  1. A table of acceptance criteria and the reported device performance: Not present.
  2. Sample sizes used for the test set and the data provenance: Not present.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present.
  4. Adjudication method for the test set: 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 present. This device is a dental restorative material, not an AI-assisted diagnostic tool.
  6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not present. This device is a dental restorative material.
  7. The type of ground truth used: Not present.
  8. The sample size for the training set: Not present.
  9. How the ground truth for the training set was established: Not present.

§ 872.3690 Tooth shade resin material.

(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.