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K Number
K040420
Device Name
DUCERAM PLUS CERAMIC SYSTEM
Manufacturer
DENTSPLY INTL.
Date Cleared
2004-03-18

(29 days)

Product Code
EIH
Regulation Number
872.6660
Type
Traditional
Panel
DE
Reference & Predicate Devices
K871808
Predicate For
K062504
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

DUCERAM® PLUS CERAMIC SYSTEM is indicated for veneering metal framework and copings for the preparation of crowns and bridges.

Device Description

The DUCERAM® PLUS CERAMIC SYSTEM is a dental ceramic veneering system for metal framework and copings. They are used by dental technicians for the preparation of crowns and bridges. DUCERAM (K871808) includes Dentine, Incisal, Transparent, Correction (add-on), Opaque, Margin, Stain and Glaze Porcelains. DUCERAM® PLUS CERAMIC SYSTEM also includes Shoulder Porcelain, Paste Opaquers, Opal Masses, and Lay Connector Paste.

AI/ML Overview

The provided text is a 510(k) Summary for the DUCERAM® PLUS CERAMIC SYSTEM, a dental ceramic veneering system. It does not contain information about acceptance criteria, device performance, or any studies conducted to prove the device meets acceptance criteria.

The summary primarily focuses on:

  • Identification: Name, address, contact, date prepared, trade/proprietary name, classification name.
  • Predicate Device: K871808 DUCERAM Metal Ceramic Dental Porcelain System.
  • Device Description: It's a dental ceramic veneering system for metal framework and copings, used by dental technicians for crowns and bridges. It specifies the components included in both the original DUCERAM and the DUCERAM® PLUS SYSTEM.
  • Intended Use: Veneering metal framework and copings for the preparation of crowns and bridges.
  • Technological Characteristics: All components have been used in legally marketed devices. The formulations are very similar to legally marketed devices and have not changed in a way that would adversely affect biocompatibility, thus no additional biocompatibility testing was deemed necessary.
  • Safety and Effectiveness Claim: The manufacturer believes prior use of components, similarity in formulations, and performance data support safety and effectiveness.

Therefore, I cannot provide the requested information in the format of a table or describe a study, as the input text does not contain such details. This document is a regulatory submission for substantial equivalence based on similarity to a predicate device, not a performance study report.

§ 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.