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K Number
K091706
Device Name
QUATTRO PORCELAIN SYSTEM
Manufacturer
DENTSPLY INTERNATIONAL, INC.
Date Cleared
2009-08-28

(79 days)

Product Code
EIH
Regulation Number
872.6660
Type
Traditional
Panel
DE
Reference & Predicate Devices
K954761
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Quattro Porcelain System is indicated for:

  1. PFM Applications: Single and multiple unit porcelain fused-to-metal fixed prosthodontic restorations.
  2. PTM Applications: Single and multiple unit porcelain pressed-to-metal fixed prosthodontic restorations.
  3. All-Ceramic Applications: Single unit anterior and posterior premolar metal-free fixed prosthodontic restorations, laminate veneers, inlays and onlays.
Device Description

The Quattro Porcelain System is an integrated porcelain system used for the fabrication of dental restorations using three major porcelain fabrication techniques: porcelain-fused-to-metal (PFM), pressed-to-metal (PTM), and pressed all-ceramic (AC). Quattro PFM and PTM are indicated for both anterior and posterior crowns and bridges. Quattro AC is indicated for anterior to pre-molar crowns, inlays and onlays, and veneers.

AI/ML Overview

The provided text describes the "Quattro Porcelain System" and its substantial equivalence to a predicate device for dental restorations. However, it does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in the context of an AI/algorithm-based medical device.

The document is a 510(k) summary for a dental porcelain system, which is a physical material, not an AI or algorithm-based device. Therefore, the types of questions posed in your request (sample sizes for test sets, data provenance, ground truth establishment, MRMC studies, standalone algorithm performance, AI assistance effect size, etc.) are not applicable to this document.

The document discusses:

  • Device Name: Quattro Porcelain System
  • Indications for Use: PFM, PTM, and All-Ceramic applications for various dental restorations.
  • Predicate Device: DENTSPLY International Finesses Low Fusing Porcelain System (K954761)
  • Technological Characteristics: Integrated system using components from legally marketed devices, with biocompatibility testing performed.
  • Non-Clinical Performance Data: Stated that the performance of the structural components (dentin and ingot porcelain) are "comparable to other legally marketed Ceramco porcelains commercially used and successful for PFM and PTM restorations." This is a general statement of comparability and not a detailed study with specific acceptance criteria and results.
  • Conclusion of Substantial Equivalence: Based on prior use of components, performance data (described as "comparable"), and biocompatibility data.

Therefore, I cannot fulfill your request using the provided text because it does not contain the information relevant to AI/algorithm performance studies. The document is for a traditional medical device (dental material) and its 510(k) clearance process.

§ 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.