FDA.reportPublic FDA data

K-Files

Primary DI
J015600297249
Brand
K-Files
Company
MICRO MEGA
Model
N010 L25
Catalog number
60029724
Device description
Endodontic instrument for professional dental use only
Published
2020-12-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
false

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
J015600297249PackageHIBCC10In Commercial Distribution
J015600297241PrimaryHIBCC0
J015600297240Unit of UseHIBCC0

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, Specify00Keep away from sunlight
Special Storage Condition, Specify00Keep dry

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
276075371
Device count
6
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
J015600406651MM K-Filesn006 L21 ISO M09600406652026-04-08
J015600406661MM K-Filesn008 L21 ISO M09600406662026-04-08
J015600406671MM K-Filesn010 L21 ISO M09600406672026-04-08
J015600406681MM K-Filesn015 L21 ISO M09600406682026-04-08
J015600406691MM K-Filesn020 L21 ISO M09600406692026-04-08
J015600406701MM K-Filesn025 L21 ISO M09600406702026-04-08
J015600406711MM K-Filesn030 L21 ISO M09600406712026-04-08
J015600406721MM K-Filesn035 L21 ISO M09600406722026-04-08
J015600406731MM K-Filesn040 L21 ISO M09600406732026-04-08
J015600406741MM K-Filesn045 L21 ISO M09600406742026-04-08
J015600406751MM K-Filesn050 L21 ISO M09600406752026-04-08
J015600406761MM K-Filesn055 L21 ISO M09600406762026-04-08
J015600406771MM K-Filesn060 L21 ISO M09600406772026-04-08
J015600406781MM K-Filesn070 L21 ISO M09600406782026-04-08
J015600406791MM K-Filesn080 L21 ISO M09600406792026-04-08
J015600406821MM K-Filesn006 L25 ISO M09600406822026-04-08
J015600406831MM K-Filesn008 L25 ISO M09600406832026-04-08
J015600406841MM K-Filesn010 L25 ISO M09600406842026-04-08
J015600406851MM K-Filesn015 L25 ISO M09600406852026-04-08
J015600406861MM K-Filesn020 L25 ISO M09600406862026-04-08

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