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K Number
K974894
Device Name
KROMATICA COLOR CHANGING ALGINATE
Manufacturer
MATECH, INC.
Date Cleared
1998-02-12

(43 days)

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

The Intended Use: This material is to be used by the dentist to produce an impression of a person's mouth/teeth and then a plaster material is poured into this impression to create a cast of the patient's mouth/ teeth.

Device Description

Kromatica Color Changing Alginate

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for the "Kromatica Color Changing Alginate" impression material (K974894). It states that the device is substantially equivalent to legally marketed predicate devices. However, this letter does not contain any information about acceptance criteria, specific performance metrics, or study details.

Therefore, I cannot provide the requested information. The document focuses solely on the regulatory clearance for marketing based on substantial equivalence. It does not include data from a clinical or performance study that would define acceptance criteria or device performance.

§ 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).