Home GUDID D80906319015R1 Endodontic Hand Instruments
Primary DI D80906319015R1
Brand Endodontic Hand Instruments
Company ROYDENT DENTAL PRODUCTS INC
Model 06319015R
Catalog number 06319015R
Device description K-File Size 015 19mm
Published 2022-11-29
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 D80906319015R1 Primary HIBCC 0 D80906319015R0 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 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 D80906321055R1 Endodontic Hand Instruments 06321055R 06321055R 2022-11-09
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