FDA.reportPublic FDA data

K File

Primary DI
00850085821195
Brand
K File
Company
CREATIVE ENDODONTIC TECHNOLOGY LLC
Model
KF-10-21MM-6PK
Device description
K File, Niti, 10, 21mm, Pack of 6
Published
2026-07-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

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
00850085821195PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850085821195008500858211958500858211950850085821195

GMDN Terms#

Term, Definition table
TermDefinition
Manual endodontic file/rasp, single-useA 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 single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
144413963
Device count
1
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
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
00850085821171K FileKF-06-21MM-6PK2026-07-21
00850085821188K FileKF-08-21MM-6PK2026-07-21
00850085821201H FilesHF-15-21MM-6PK2026-07-21
00850085821003Legacy UniversalLU-SX-19MM-6PK2026-04-17
00850085821010Legacy FilesLF-21MM-6PK2026-04-17
00850085821027Legacy FilesLF-25MM-6PK2026-04-17
00850085821034Legacy FilesLF-31MM-6PK2026-04-17
00850085821041Canal Pro SystemCPS-21MM-6PK2026-04-17
00850085821058Canal Pro SystemCPS-25MM-6PK2026-04-17
00850085821065Canal Pro SystemCPS-31MM-6PK2026-04-17
00850085821072Canal EaseCE-21MM-6PK2026-04-17
00850085821089Canal EaseCE-25MM-6PK2026-04-17
00850085821096Scout FilesSF-014-21MM-6PK2026-04-17
00850085821102Scout FilesSF-015-21MM-6PK2026-04-17
00850085821119CET Gate DrillsGD-2-28MM-6PK2026-04-17
00850085821126CET Gate DrillsGD-3-28MM-6PK2026-04-17
00850085821133CET Gutta Percha Points04GP-20-60PK2026-04-17
00850085821140CET Gutta Percha Points04GP-25-60PK2026-04-17
00850085821157CET Gutta Percha Points06GP-20-60PK2026-04-17
00850085821164CET Gutta Percha Points06GP-25-60PK2026-04-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850085821171K FileCREATIVE ENDODONTIC TECHNOLOGY LLCEKS2026-07-21
00850085821188K FileCREATIVE ENDODONTIC TECHNOLOGY LLCEKS2026-07-21
00850085821201H FilesCREATIVE ENDODONTIC TECHNOLOGY LLCEKS2026-07-21
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