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K Number
K042878
Device Name
FLEXITIME XTREME
Manufacturer
HERAEUS KULZER, INC.
Date Cleared
2004-12-17

(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

Flexitime Xtreme is a polyvinylsiloxane silicone impression material used for all inlay, crown and bridge, edentulous and partial impressions.

Device Description

Flexitime Xtreme is a polyvinylsiloxane silicone impression material.

AI/ML Overview

This document is a 510(k) clearance letter for a dental impression material, Flexitime Xtreme. It does not contain information about acceptance criteria or a study proving device performance in the context of AI/machine learning. Therefore, I cannot extract the requested information.

§ 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).