| Primary Device ID | 06944835173321 |
| NIH Device Record Key | 65fe6436-e14f-4471-8c23-c359409ceb2b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DIA-X FILE |
| Version Model Number | 21mm D3 |
| Catalog Number | 571-S103 |
| Company DUNS | 687789453 |
| Company Name | DiaDent Group International |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | false |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06944835173321 [Primary] |
| EKS | File, Pulp Canal, Endodontic |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[06944835173321]
Moist Heat or Steam Sterilization
[06944835173321]
Moist Heat or Steam Sterilization
[06944835173321]
Moist Heat or Steam Sterilization
[06944835173321]
Moist Heat or Steam Sterilization
[06944835173321]
Moist Heat or Steam Sterilization
[06944835173321]
Moist Heat or Steam Sterilization
[06944835173321]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-03-02 |
| Device Publish Date | 2026-02-20 |
| 06944835173451 | Dia-X File is a file used for root canal treatment in dentistry. |
| 06944835173444 | Dia-X File is a file used for root canal treatment in dentistry. |
| 06944835173420 | Dia-X File is a file used for root canal treatment in dentistry. |
| 06944835173413 | Dia-X File is a file used for root canal treatment in dentistry. |
| 06944835173406 | Dia-X File is a file used for root canal treatment in dentistry. |
| 06944835173390 | Dia-X File is a file used for root canal treatment in dentistry. |
| 06944835173383 | Dia-X File is a file used for root canal treatment in dentistry. |
| 06944835173376 | Dia-X File is a file used for root canal treatment in dentistry. |
| 06944835173369 | Dia-X File is a file used for root canal treatment in dentistry. |
| 06944835173345 | Dia-X File is a file used for root canal treatment in dentistry. |
| 06944835173338 | Dia-X File is a file used for root canal treatment in dentistry. |
| 06944835173321 | Dia-X File is a file used for root canal treatment in dentistry. |
| 06944835173314 | Dia-X File is a file used for root canal treatment in dentistry. |
| 06944835173307 | Dia-X File is a file used for root canal treatment in dentistry. |
| 06944835173291 | Dia-X File is a file used for root canal treatment in dentistry. |
| 06944835131345 | Dia-X File is a file used for root canal treatment in dentistry. |
| 06944835131338 | Dia-X File is a file used for root canal treatment in dentistry. |
| 06944835131154 | Dia-X File is a file used for root canal treatment in dentistry. |
| 06944835131147 | Dia-X File is a file used for root canal treatment in dentistry. |