FDA.reportPublic FDA data

C-Root

Primary DI
06972902588136
Brand
C-Root
Company
Beijing C-Root Dental Medical Devices Co., LTD.
Model
025/08 19mm
Catalog number
file 025/08 19mm
Published
2026-05-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
06972902588136PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06972902588136069729025881366972902588136

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.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
415018580
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06972902580024C-Root0.5g*212026-06-10
06972902580062C-Root0.5g2026-06-10
06972902580079C-Root1g2026-06-10
06972902580093C-Root3g2026-06-10
06972902580109C-Root4g2026-06-10
06972902580116C-Root5g2026-06-10
06972902580123C-Root6g2026-06-10
06972902580130C-Root10g2026-06-10
06972902580147C-Root15g2026-06-10
06972902580154C-Root20g2026-06-10
06972902580161C-Root25g2026-06-10
06972902587122C-Root015/02 16mmfile 015/02 16mm2026-06-10
06972902587139C-Root016/02 16mmfile 016/02 16mm2026-06-10
06972902587146C-Root019/02 16mmfile 019/02 16mm2026-06-10
06972902582325C-Root2g*42026-05-15
06972902583292C-Root1g2026-05-15
06972902583308C-Root0.5g2026-05-15
06972902588129C-Root 020/08 19mm file 020/08 19mm2026-05-15
06972902588143C-Root 015/09 19mm file 015/09 19mm2026-05-15
06972902588150C-Root 020/09 19mm file 020/09 19mm2026-05-15

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