Home GUDID D80907321020R1 Endodontic Hand Instruments
Primary DI D80907321020R1
Brand Endodontic Hand Instruments
Company ROYDENT DENTAL PRODUCTS INC
Model 06319015R
Catalog number 07321020R
Device description HEDSTROM FILES 21MM 20
Published 2022-11-09
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Sterile true
Single use true Product Codes# Code, Name table Code Name EKS FILE, PULP CANAL, ENDODONTIC
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class EKS File, Pulp Canal, Endodontic Dental 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status D80907321020R1 Primary HIBCC 0 D80907321020R0 Unit of Use HIBCC 0
GMDN Terms# Term, Definition table Term Definition Rotary/reciprocating endodontic file/rasp, single-use A dental endpiece designed to be attached to a rotary or reciprocating dental power tool handpiece to debride and enlarge the root canal and smooth its walls by cutting or abrasion. It is made of metal [e.g., stainless steel, nickel-titanium alloy (Nitinol)] and its working end has a polygonal cross-section with edges. It may also be referred to as a rotary or engine file, or reamer. This is a single-use device.
Regulatory Flags# DUNS number 131487225 Device count 6 Premarket exempt true Lot or batch 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
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 07630049901858 rootEX instrument short 0,8 mm, pu: 6 Diaswiss SA EKS 2023-10-02 07630049902053 K-Files 21mm 010, pu: 6 pcs Diaswiss SA EKS 2023-10-02 07630049950856 rootEX instrument short 1,3 mm, pu: 6 Diaswiss SA EKS 2023-10-02 07630049950870 rootEX instrument short 1,8 mm, pu: 6 Diaswiss SA EKS 2023-10-02 07630049950917 rootEX instrument long 0,8 mm, pu: 6 p Diaswiss SA EKS 2023-10-02 07630049950931 rootEX instrument long 1,3 mm, pu: 6 p Diaswiss SA EKS 2023-10-02 07630049950955 rootEX instrument long 1,8 mm, pu: 6 p Diaswiss SA EKS 2023-10-02 07630049952584 rootEX drill short shank 0,8 mm, pu: 6 Diaswiss SA EKS 2023-10-02 07630049952591 rootEX drill short shank 1,1 mm, pu: 6 Diaswiss SA EKS 2023-10-02 07630049986831 K-Files 29mm 008, pu: 6 pcs Diaswiss SA EKS 2023-10-02 07630049986848 K-Files 29mm 010, pu: 6 pcs Diaswiss SA EKS 2023-10-02 07630049986862 K-Files 29mm 015, pu: 6 pcs Diaswiss SA EKS 2023-10-02 07630049986886 K-Files 29mm 020, pu: 6 pcs Diaswiss SA EKS 2023-10-02 07630049986909 K-Files 29mm 025, pu: 6 pcs Diaswiss SA EKS 2023-10-02 07630049986923 K-Files 29mm 030, pu: 6 pcs Diaswiss SA EKS 2023-10-02 07630049986947 K-Files 29mm 035, pu: 6 pcs Diaswiss SA EKS 2023-10-02 07630049986961 K-Files 29mm 040, pu: 6 pcs Diaswiss SA EKS 2023-10-02 07630049986985 K-Files 29mm 045, pu: 6 pcs Diaswiss SA EKS 2023-10-02 07630049987005 K-Files 29mm 050, pu: 6 pcs Diaswiss SA EKS 2023-10-02 07630049987029 K-Files 29mm 055, pu: 6 pcs Diaswiss SA EKS 2023-10-02 07630049987043 K-Files 29mm 060, pu: 6 pcs Diaswiss SA EKS 2023-10-02 07630049987067 K-Files 29mm 070, pu: 6 pcs Diaswiss SA EKS 2023-10-02 07630049987081 K-Files 29mm 080, pu: 6 pcs Diaswiss SA EKS 2023-10-02 07630049987203 Hedstroem files 21mm 055, pu: 6 pcs Diaswiss SA EKS 2023-10-02 07630049987357 Hedstroem files 25mm 055, pu: 6 pcs Diaswiss SA EKS 2023-10-02 07630049987401 Hedstroem files 29mm 008, pu: 6 pcs Diaswiss SA EKS 2023-10-02 07630049987418 Hedstroem files 29mm 010, pu: 6 pcs Diaswiss SA EKS 2023-10-02 07630049987432 Hedstroem files 29mm 015, pu: 6 pcs Diaswiss SA EKS 2023-10-02 07630049987456 Hedstroem files 29mm 020, pu: 6 pcs Diaswiss SA EKS 2023-10-02 07630049987470 Hedstroem files 29mm 025, pu: 6 pcs Diaswiss SA EKS 2023-10-02