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K Number
K030914
Device Name
REBILDA DC
Manufacturer
VOCO GMBH
Date Cleared
2003-05-30

(67 days)

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

Core build-up of vital and non-vital teeth

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) Pre-Market Notification letter from the FDA regarding a dental device called "Rebilda DC." This document primarily focuses on classifying the device and determining its substantial equivalence to predicate devices, rather than detailing a specific study proving the device meets acceptance criteria.

Therefore, the information requested in the prompt based on a study of the device's performance is largely not present in the provided text. The document is an administrative letter of approval, not a scientific study report.

However, I can extract the following limited information:

  • Trade/Device Name: Rebilda® DC
  • Regulation Name: Tooth Shade Resin Material
  • Regulatory Class: II
  • Product Code: EBF
  • Indications for Use: Core build-up of vital and non-vital teeth

Regarding the specific questions in the prompt:

  1. A table of acceptance criteria and the reported device performance: This information is not available in the provided FDA letter. The letter confirms substantial equivalence, which implies the device meets certain performance standards comparable to existing devices, but it does not detail specific acceptance criteria or reported performance data.
  2. Sample size used for the test set and the data provenance: Not available.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available.
  4. Adjudication method for the test set: Not available.
  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 available. This is a dental material, not an AI-assisted diagnostic tool.
  6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not available. As mentioned, this is a dental material.
  7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not available.
  8. The sample size for the training set: Not available.
  9. How the ground truth for the training set was established: Not available.

In summary, the provided FDA letter confirms the substantial equivalence of the Rebilda DC device to predicate devices for its intended use, allowing it to be marketed. However, it does not contain the detailed study results, acceptance criteria, or performance data typically found in a scientific or clinical study report.

§ 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.