FDA.reportPublic FDA data

M-access® HEDSTROEM FILE

Primary DI
J003A16MA021900121
Brand
M-access® HEDSTROEM FILE
Company
MAILLEFER INSTRUMENTS HOLDING Sàrl
Model
A16MA02190012
Catalog number
A16MA02190012
Device description
Endodontic Instrument
Published
2022-09-30
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
EKSFILE, PULP CANAL, ENDODONTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKSFile, Pulp Canal, EndodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
J003A16MA021900121PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Manual endodontic file/rasp, reusableA hand-held manual dental instrument designed to debride and enlarge the root canal and smooth its walls by a cutting or abrasive action when moved in a longitudinal direction. 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 an endodontic reamer. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00N/A

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
480538495
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
J003PTGGPAST1Protaper Gold Conform FitPTGGPASTPTGGPAST2026-05-13
J003PTGGPF11Protaper Gold Conform FitPTGGPF1PTGGPF12026-05-13
J003PTGGPF21Protaper Gold Conform FitPTGGPF2PTGGPF22026-05-13
J003PTGGPF31Protaper Gold Conform FitPTGGPF3PTGGPF32026-05-13
J003PTGGPF41Protaper Gold Conform FitPTGGPF4PTGGPF42026-05-13
J003PTGGPF51Protaper Gold Conform FitPTGGPF5PTGGPF52026-05-13
J003PTNGPX21Protaper Next Conform FitPTNGPX2PTNGPX22026-05-13
J003PTNGPX31Protaper Next Conform FitPTNGPX3PTNGPX32026-05-13
J003PTNGPX41Protaper Next Conform FitPTNGPX4PTNGPX42026-05-13
J003PTNGPX51Protaper Next Conform FitPTNGPX5PTNGPX52026-05-13
J003PTUGPAST1Protaper Universal Conform FitPTUGPASTPTUGPAST2026-05-13
J003PTUGPF11Protaper Universal Conform FitPTUGPF1PTUGPF12026-05-13
J003PTUGPF21Protaper Universal Conform FitPTUGPF2PTUGPF22026-05-13
J003PTUGPF31Protaper Universal Conform FitPTUGPF3PTUGPF32026-05-13
J003PTUGPF41Protaper Universal Conform FitPTUGPF4PTUGPF42026-05-13
J003PTUGPF51Protaper Universal Conform FitPTUGPF5PTUGPF52026-05-13
J003PULGAST1Protaper Ultimate Conform FitPULGASTPULGAST2026-05-13
J003PULGF11Protaper Ultimate Conform FitPULGF1PULGF12026-05-13
J003PULGF21Protaper Ultimate Conform FitPULGF2PULGF22026-05-13
J003PULGF31Protaper Ultimate Conform FitPULGF3PULGF32026-05-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810213812419EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812426EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812433EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812440EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812457EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812464EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812471EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812488EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812495EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812501EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812518EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812525EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812532EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812549EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812556EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812563EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812570EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812587EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812594EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812600EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812617EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812624EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812631EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812648EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812655EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812662EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812679EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812686EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812693EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812709EdgeEndoHSG-S Corp.EKS2026-06-24