Home GUDID D8090525060Z0 Gutta Percha Points
Primary DI D8090525060Z0
Brand Gutta Percha Points
Company ROYDENT DENTAL PRODUCTS INC
Model 0525060Z
Catalog number 0525060Z
Device description Gutta Percha Points GP ISO Cst CCE 60
Published 2022-10-27
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC false
Sterile false
Single use true Product Codes# Code, Name table Code Name EKM GUTTA-PERCHA
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class EKM Gutta-Percha Dental 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status D8090525060Z1 Primary HIBCC 0 D8090525060Z0 Unit of Use HIBCC 0
GMDN Terms# Term, Definition table Term Definition Synthetic gutta-percha A dental material made from a polymer-based, synthetic gutta-percha containing fillers and radiopacifiers in a soft resin matrix, intended to fill the root canal of a tooth. This material has the ability to resist leakage significantly better than natural gutta-percha based obturation whilst strengthening the root resulting in roots having a coronal and apical seal as part of the canal filling process. After application, this device cannot be reused.
Sterilization Methods# Method table Method Liquid Chemical
Regulatory Flags# DUNS number 131487225 Device count 120 DM exempt false Premarket exempt true HCT/P false Kit false Combination product false Lot or batch false Serial number false Manufacturing date on label false Expiration date on label false Donation ID number false Contains natural rubber latex true No natural rubber latex false Sterilization required before use true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published D80906319015R1 Endodontic Hand Instruments 06319015R 06319015R 2022-11-29 D80906319015R0 Endodontic Hand Instruments 06319015R 06319015R 2022-11-29 D80906319010R1 Endodontic Hand Instruments 06319010R 06319010R 2022-11-10 D80906319010R0 Endodontic Hand Instruments 06319010R 06319010R 2022-11-10 D80906319020R1 Endodontic Hand Instruments 06319020R 06319020R 2022-11-09 D80906319025R1 Endodontic Hand Instruments 06319025R 06319025R 2022-11-09 D80906319160R1 Endodontic Hand Instruments 06319160R 06319160R 2022-11-09 D80906321006R1 Endodontic Hand Instruments 06321006R 06321006R 2022-11-09 D80906321008R1 Endodontic Hand Instruments 06321008R 06321008R 2022-11-09 D80906321010R1 Endodontic Hand Instruments 06321010R 06321010R 2022-11-09 D80906321012R1 Endodontic Hand Instruments 06321012R 06321012R 2022-11-09 D80906321015R1 Endodontic Hand Instruments 06321015R 06321015R 2022-11-09 D80906321017R1 Endodontic Hand Instruments 06321017R 06321017R 2022-11-09 D80906321020R1 Endodontic Hand Instruments 06321020R 06321020R 2022-11-09 D80906321025R1 Endodontic Hand Instruments 06321025R 06321025R 2022-11-09 D80906321030R1 Endodontic Hand Instruments 06321030R 06321030R 2022-11-09 D80906321035R1 Endodontic Hand Instruments 06321035R 06321035R 2022-11-09 D80906321040R1 Endodontic Hand Instruments 06321040R 06321040R 2022-11-09 D80906321045R1 Endodontic Hand Instruments 06321045R 06321045R 2022-11-09 D80906321050R1 Endodontic Hand Instruments 06321050R 06321050R 2022-11-09
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