FDA.reportPublic FDA data

Scout Files

Primary DI
00850085821102
Brand
Scout Files
Company
CREATIVE ENDODONTIC TECHNOLOGY LLC
Model
SF-015-21MM-6PK
Device description
Scout Rotary File, 015, 21mm, Pack of 6
Published
2026-04-17
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
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
00850085821102PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850085821102008500858211028500858211020850085821102

GMDN Terms#

Term, Definition table
TermDefinition
Rotary/reciprocating endodontic file/rasp, single-useA 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
144413963
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
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
00850085821195K FileKF-10-21MM-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
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
00850085821195K 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