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K Number
K053018
Device Name
POLY SILOXANE IMPRESSION MATERIAL
Manufacturer
MILLENNIUM DENTAL INTERNATIONAL, INC.
Date Cleared
2005-11-08

(13 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

Device intended to be placed intraorally or on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums.

Device Description

Multiple (POLY SILOXANE IMPRESSION MATERIAL)

AI/ML Overview

I am sorry but this document does not contain the information you are looking for. This document is a letter from the FDA to Millennium Dental International, Incorporated regarding their 510(k) premarket notification for a POLY Siloxane Impression Material. It confirms that the device is substantially equivalent to legally marketed predicate devices and is subject to general controls. The document does not describe the acceptance criteria and the study that proves the device meets the acceptance criteria.

§ 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).