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K Number
K062506
Device Name
INCORIS AL
Manufacturer
SIRONA DENTAL SYSTEMS GMBH
Date Cleared
2006-09-08

(11 days)

Product Code
EIH
Regulation Number
872.6660
Type
Traditional
Panel
DE
Reference & Predicate Devices
K012506
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

inCoris AL are indicated for use as a substructure for porcelain fused ceramic fixed dental restorations; for single unit anterior or posterior crowns and 3 unit anterior bridges.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain the acceptance criteria, device performance, or details about a study to prove the device meets these criteria. The document is a 510(k) clearance letter from the FDA for the "inCoris AL" device, indicating that it has been found substantially equivalent to a legally marketed predicate device.

The document includes:

  • Trade/Device Name: Incoris AL
  • Regulation Number: 21 CFR 872.6660
  • Regulation Name: Porcelain Powder for Clinical Use
  • Regulatory Class: II
  • Product Code: EIH
  • Indications for Use: as a substructure for porcelain fused ceramic fixed dental restorations; for single unit anterior or posterior crowns and 3 unit anterior bridges. Substructures of inCoris AL for CEREC are machined using the CEREC 2, CEREC 3 and inLab CAD/CAM systems.

However, it does not provide any specific information regarding:

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

This document is a regulatory approval letter, not a scientific study report or a summary of performance data.

§ 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.