LogoFDA 510(k) Search
K Number
K982007
Device Name
TRUBYTE DENTURE BOND DENTURE BONDING AGENT
Manufacturer
DENTSPLY INTL.
Date Cleared
1998-07-22

(44 days)

Product Code
KLE,EBI
Regulation Number
872.3200
Type
Traditional
Panel
DE
Reference & Predicate Devices
K924422
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

TRUBYTE® DENTURE BOND Denture Bonding Agent is used to bond plastic denture teeth and denture reline materials to acrylic denture bases.

Device Description

TRUBYTE® DENTURE BOND Denture Bonding Agent is a polymer/ monomer liquid solution. It is compatible with both heat-cured and auto-polymerizable acrylic denture base resins.

AI/ML Overview

Here's a breakdown of the requested information based on the provided text:

1. Table of acceptance criteria and reported device performance:

Acceptance Criteria (Stated Goal)Reported Device Performance
Not affect the amount of residual monomer present in the denture base"There is not a statistically significant difference in residual monomer between samples that utilized TRUBYTE® DENTURE BOND Denture Bonding Agent vs. those prepared without bonding agent. This analysis confirms that TRUBYTE® DENTURE BOND Denture Bonding Agent use does not affect the amount of residual monomer present in the denture base."

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

  • Sample size for test set: Not explicitly stated. The text mentions "denture samples" but does not provide a specific number.
  • Data provenance: Not explicitly stated, but the study was conducted by DENTSPLY International as part of their 510(k) submission. It's likely a prospective study conducted in a lab setting, but this is an inference. There's no information on the country of origin of the data beyond DENTSPLY's location (York, PA, USA).

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

  • Number of experts: Not applicable. The ground truth was established through a quantitative chemical analysis (Gas chromatographic analysis).
  • Qualifications of experts: Not applicable.

4. Adjudication method for the test set:

  • Adjudication method: Not applicable. The ground truth was established through a quantitative chemical analysis, not expert review.

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:

  • MRMC study: No, this type of study was not performed. The device is a bonding agent, not an AI-assisted diagnostic tool.
  • Effect size: Not applicable.

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

  • Standalone performance: No, this concept is not applicable. The device is a chemical bonding agent, not an algorithm. The performance evaluation was on the chemical properties of the material.

7. The type of ground truth used:

  • Type of ground truth: Quantitative chemical measurement (Gas chromatographic analysis of residual methyl methacrylate monomer).

8. The sample size for the training set:

  • Sample size for training set: Not applicable. The device is a chemical product, not a machine learning algorithm requiring a training set.

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

  • How ground truth for training set was established: Not applicable.

§ 872.3200 Resin tooth bonding agent.

(a)
Identification. A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.(b)
Classification. Class II.