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K Number
K103556
Device Name
IPS E.MAX CAD CRYSTALL / CONNECT AND IPS E.MAX CAD CRYSTAL / ADD-ON CONNECT (FOR CAD-ON TECHNIQUE)
Manufacturer
IVOCLAR VIVADENT, INC.
Date Cleared
2011-04-13

(132 days)

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

IPS e.max® CAD Crystall/Connect and IPS e.max® CAD Crystall/Add-On Connect (for CAD-On Technique) is intended to be used for the fabrication of:
Crowns
Splinted crowns
3-4 unit bridges
Crown, splinted crown or 3-4 unit bridge placed on top of an implant abutment ._

Device Description

Not Found

AI/ML Overview

This document is an FDA 510(k) clearance letter for a dental device, not a study report or technical specification document. Therefore, it does not contain the detailed information required to answer your request about acceptance criteria and a study proving a device meets those criteria.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..."

This means the FDA granted clearance based on substantial equivalence to existing devices, not necessarily on a new standalone study proving performance against defined acceptance criteria for a novel device.

Therefore, I cannot provide the requested information, which would typically be found in a clinical study report or a detailed test report. The document only contains:

  • Device Name: IPS e.max® CAD Crystall/Connect and IPS e.max® CAD Crystall/Add-on Connect (for CAD-On Technique)
  • Regulation Number: 21 CFR 872.6660
  • Regulation Name: Porcelain Powder for Clinical use
  • Regulatory Class: II
  • Product Code: EIH
  • Indications For Use: Crowns, Splinted crowns, 3-4 unit bridges, Crown, splinted crown or 3-4 unit bridge placed on top of an implant abutment.

The acceptance criteria, study details, sample sizes, ground truth establishment, and expert information are not present in this regulatory clearance letter.

§ 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.