Home GUDID D80906319015R0 Endodontic Hand Instruments
Primary DI D80906319015R0
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
Rx false
OTC false
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 DM exempt false Premarket exempt true HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false 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 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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