EXAFLEX IMPRESSION MATERIAL (MODIFICATION)

• K Number: K955932
• Device Name: EXAFLEX IMPRESSION MATERIAL (MODIFICATION)
• Manufacturer: GC AMERICA, INC.
• Date Cleared: 1996-03-11 ( 89 days)
• Product Code: ELW
• Regulation Number: 872.3660
• Type: Traditional
• Panel: Dental
• Age Range: N/A
• Reference & Predicate Devices: N/A
• Predicate For: K181011 , K973343

Intended Use

Get notified when PDF is available

Device Description

Get notified when PDF is available

AI/ML Overview

Get notified when PDF is available

Summary

Loading...

Regulation Number and Section

§ 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).