DIA-X FILE 571-S291

GUDID 06944835131154

Dia-X File is a file used for root canal treatment in dentistry.

DiaDent Group International

Rotary/reciprocating endodontic file/rasp, single-use
Primary Device ID06944835131154
NIH Device Record Key9c600099-834c-4f2e-b9f3-ec87a0401493
Commercial Distribution StatusIn Commercial Distribution
Brand NameDIA-X FILE
Version Model Number25mm D1/D4 Asst
Catalog Number571-S291
Company DUNS687789453
Company NameDiaDent Group International
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry

Device Identifiers

Device Issuing AgencyDevice ID
GS106944835131154 [Primary]

FDA Product Code

EKSFile, Pulp Canal, Endodontic

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[06944835131154]

Moist Heat or Steam Sterilization


[06944835131154]

Moist Heat or Steam Sterilization


[06944835131154]

Moist Heat or Steam Sterilization


[06944835131154]

Moist Heat or Steam Sterilization


[06944835131154]

Moist Heat or Steam Sterilization


[06944835131154]

Moist Heat or Steam Sterilization


[06944835131154]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-03-02
Device Publish Date2026-02-20

On-Brand Devices [DIA-X FILE]

06944835173451Dia-X File is a file used for root canal treatment in dentistry.
06944835173444Dia-X File is a file used for root canal treatment in dentistry.
06944835173420Dia-X File is a file used for root canal treatment in dentistry.
06944835173413Dia-X File is a file used for root canal treatment in dentistry.
06944835173406Dia-X File is a file used for root canal treatment in dentistry.
06944835173390Dia-X File is a file used for root canal treatment in dentistry.
06944835173383Dia-X File is a file used for root canal treatment in dentistry.
06944835173376Dia-X File is a file used for root canal treatment in dentistry.
06944835173369Dia-X File is a file used for root canal treatment in dentistry.
06944835173345Dia-X File is a file used for root canal treatment in dentistry.
06944835173338Dia-X File is a file used for root canal treatment in dentistry.
06944835173321Dia-X File is a file used for root canal treatment in dentistry.
06944835173314Dia-X File is a file used for root canal treatment in dentistry.
06944835173307Dia-X File is a file used for root canal treatment in dentistry.
06944835173291Dia-X File is a file used for root canal treatment in dentistry.
06944835131345Dia-X File is a file used for root canal treatment in dentistry.
06944835131338Dia-X File is a file used for root canal treatment in dentistry.
06944835131154Dia-X File is a file used for root canal treatment in dentistry.
06944835131147Dia-X File is a file used for root canal treatment in dentistry.

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