DIA-X FILE 571-S101

GUDID 06944835173307

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 ID06944835173307
NIH Device Record Key55b0296a-1868-400c-9894-a39bc4496a6d
Commercial Distribution StatusIn Commercial Distribution
Brand NameDIA-X FILE
Version Model Number21mm D1
Catalog Number571-S101
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
GS106944835173307 [Primary]

FDA Product Code

EKSFile, Pulp Canal, Endodontic

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[06944835173307]

Moist Heat or Steam Sterilization


[06944835173307]

Moist Heat or Steam Sterilization


[06944835173307]

Moist Heat or Steam Sterilization


[06944835173307]

Moist Heat or Steam Sterilization


[06944835173307]

Moist Heat or Steam Sterilization


[06944835173307]

Moist Heat or Steam Sterilization


[06944835173307]

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.

© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.