LogoFDA 510(k) Search
K Number
K070677
Device Name
COLORISE
Manufacturer
ZHERMACK S.P.A.
Date Cleared
2007-05-11

(60 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

COLORISE is a conventional two-component (base/catalyst) polyvinylsiloxane (VPS) dental impression material intended and used to reproduce the structure of a patient`s teeth and gums.

Device Description

COLORISE is a conventional two-component (base/catalyst) polyvinylsiloxane (VPS) dental impression material.

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a dental impression material named COLORISE. It does not contain information about acceptance criteria or a study proving that the device meets those criteria. This type of information is typically found in the 510(k) summary or premarket notification submission itself, not in the clearance letter.

Therefore, I cannot provide the requested information based on the provided text.

§ 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).