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K Number
K033667
Device Name
CARRARA PRESS SYSTEM
Manufacturer
DENTSPLY INTL.
Date Cleared
2004-01-23

(63 days)

Product Code
EIH
Regulation Number
872.6660
Type
Traditional
Panel
Dental
Reference & Predicate Devices
K993897
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

CARRARA PRESS SYSTEM is intended for the fabrication of ceramic crowns, inlays, onlays or venecrs. Fabrication of ceramic crowns, inlays, onlays, or veneers.

Device Description

CARRARA PRESS SYSTEM is a porcelain system used for the fabrication of all-ceramic dental restorations. The system includes a core ceramic, press inlay ceramic, conditioner, and glaze.

AI/ML Overview

The provided text is a 510(k) summary for the DENTSPLY International CARRARA PRESS SYSTEM, a porcelain system for dental restorations. It does not contain information about acceptance criteria, device performance metrics, or a study design. Instead, it focuses on demonstrating substantial equivalence to a predicate device based on prior market history and material similarities.

Therefore, I cannot fulfill your request for:

  1. A table of acceptance criteria and reported device performance.
  2. Sample sizes or data provenance for a test set.
  3. Number or qualifications of experts for ground truth.
  4. Adjudication method for a test set.
  5. MRMC comparative effectiveness study or effect size.
  6. Standalone algorithm performance.
  7. Type of ground truth used.
  8. Sample size for a training set.
  9. How ground truth for the training set was established.

The document explicitly states: "We believe that the prior use of the components of CARRARA PRESS SYSTEM in legally marketed devices, and the historical use of the device in Europe provide sufficient evidence of the safety and effectiveness of CARRARA PRESS SYSTEM for the indicated uses." This indicates that the regulatory approval was based on demonstrating equivalence rather than a new performance study with specific acceptance criteria.

§ 872.6660 Porcelain powder for clinical use.

(a)
Identification. Porcelain powder for clinical use is a device consisting of a mixture of kaolin, felspar, quartz, or other substances intended for use in the production of artificial teeth in fixed or removable dentures, of jacket crowns, facings, and veneers. The device is used in prosthetic dentistry by heating the powder mixture to a high temperature in an oven to produce a hard prosthesis with a glass-like finish.(b)
Classification. Class II.