FDA.reportPublic FDA data

DIA-X FILE

Primary DI
06944835173444
Brand
DIA-X FILE
Company
DiaDent Group International
Model
25mm D6
Catalog number
571-S206
Device description
Dia-X File is a file used for root canal treatment in dentistry.
Published
2026-02-20
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
06944835173444PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06944835173444069448351734446944835173444

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Dry

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
687789453
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
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
06944835173291DIA-X FILE19mm DX571-S1002026-02-20
06944835173314DIA-X FILE21mm D2571-S1022026-02-20
06944835173321DIA-X FILE21mm D3571-S1032026-02-20
06944835173369DIA-X FILE21mm D6571-S1062026-02-20
06944835173376DIA-X FILE21mm D7571-S1072026-02-20
06944835173451DIA-X FILE25mm D7571-S2072026-02-20
08806383585873DiaCemTempNEDiaCemTempNE 10g (A type)A2003-31012022-08-16
08806383585897DiaCemTempNEDiaCemTempNE 10g (B type)A2003-31022022-08-16
08806383585910DiaCemTempNEDiaCemTempNE 10g (C type)A2003-31032022-08-16
08806383585934DiaCemTempNEDiaCemTempNE 3gA2003-61022022-08-16
08806383525039DIA-X FILE19mm DX571-S1002026-06-15
08806383525046DIA-X FILE21mm D1571-S1012026-02-20
08806383525077DIA-X FILE21mm D4571-S1042026-02-20
08806383525084DIA-X FILE21mm D5571-S1052026-02-20
08806383525091DIA-X FILE21mm D1/D4 Asst571-S1912026-02-20
08806383525107DIA-X FILE19mm/21mm DX/D3 Asst571-S1922026-02-20
08806383525114DIA-X FILE25mm D1571-S2012026-02-20
08806383525121DIA-X FILE25mm D2571-S2022026-02-20
08806383525138DIA-X FILE25mm D3571-S2032026-02-20
08806383525145DIA-X FILE25mm D4571-S2042026-02-20

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