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K Number
K061267
Device Name
SIMULATE, COLOR CHANGE ALGINATE
Manufacturer
CAVEX HOLLAND B.V.
Date Cleared
2006-07-10

(66 days)

Product Code
ELW
Regulation Number
872.3660
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Simulate, Color Change Alginate is a dental impression material based on alginate. It is used for taking impressions of the oral cavity with the purpose of constructing a gypsum cast that is a copy of the situation in the mouth. It is a general purpose impression material for making study models, first impressions for the construction of individual trays, situation models, orthodontic impressions etc.

Simulate, Color Change Alginate has the special characteristic of being a colorchanging alginate: it becomes violet upon contact with water in the mixing bowl, changes to pink indicating the end of the mixing time and then finally changes to white indicating the end of the setting time in the mouth.

Device Description

Simulate, Color Change Alginate is a dental impression material based on alginate. It has the special characteristic of being a colorchanging alginate: it becomes violet upon contact with water in the mixing bowl, changes to pink indicating the end of the mixing time and then finally changes to white indicating the end of the setting time in the mouth.

AI/ML Overview

I am sorry, but the provided text is a 510(k) clearance letter from the FDA. This document does not contain any information about acceptance criteria or a study proving device performance.

A 510(k) clearance letter indicates that the FDA has determined a new medical device is substantially equivalent to a legally marketed predicate device. It primarily focuses on the regulatory approval process, product classification, and general controls the manufacturer must adhere to.

To answer your request, I would need a different type of document, such as:

  • A clinical trial report
  • A validation study protocol or report
  • A scientific publication detailing the device's performance evaluation
  • The 510(k) submission itself (which often includes such data, but is not the clearance letter)

Without such a document, I cannot extract the information you've requested.

§ 872.3660 Impression material.

(a)
Identification. Impression material is a device composed of materials such as alginate or polysulfide intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures.(b)
Classification. Class II (Special Controls).