| Primary Device ID | 07640142416005 |
| NIH Device Record Key | 358f8d4c-58e5-4de6-9d49-0503fd042c08 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | K-FILES |
| Version Model Number | 01.154.31.045.CG |
| Catalog Number | 01.154.31.045.CG |
| Company DUNS | 482884061 |
| Company Name | FKG Dentaire Sàrl |
| Device Count | 1 |
| DM Exempt | true |
| 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 | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07640142416005 [Primary] |
| EKS | File, Pulp Canal, Endodontic |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[07640142416005]
Moist Heat or Steam Sterilization
[07640142416005]
Moist Heat or Steam Sterilization
[07640142416005]
Moist Heat or Steam Sterilization
[07640142416005]
Moist Heat or Steam Sterilization
[07640142416005]
Moist Heat or Steam Sterilization
[07640142416005]
Moist Heat or Steam Sterilization
[07640142416005]
Moist Heat or Steam Sterilization
[07640142416005]
Moist Heat or Steam Sterilization
[07640142416005]
Moist Heat or Steam Sterilization
[07640142416005]
Moist Heat or Steam Sterilization
[07640142416005]
Moist Heat or Steam Sterilization
[07640142416005]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-08-22 |
| Device Publish Date | 2022-08-14 |
| 07640142416081 | K-Files 154, 31 mm, # Nr 45-80, handle SMG |
| 07640142416074 | K-Files 154, 31 mm, # 15-40, handle SMG |
| 07640142416067 | K-Files 154, 31 mm, # 06-25, handle SMG |
| 07640142416050 | K-Files 154, 31 mm, # 80, handle SMG |
| 07640142416043 | K-Files 154, 31 mm, # 70, handle SMG |
| 07640142416036 | K-Files 154, 31 mm, # 60, handle SMG |
| 07640142416029 | K-Files 154, 31 mm, # 55, handle SMG |
| 07640142416012 | K-Files 154, 31 mm, # 50, handle SMG |
| 07640142416005 | K-Files 154, 31 mm, # 45, handle SMG |
| 07640142415992 | K-Files 154, 31 mm, # 40, handle SMG |
| 07640142415985 | K-Files 154, 31 mm, # 35, handle SMG |
| 07640142415978 | K-Files 154, 31 mm, # 30, handle SMG |
| 07640142415961 | K-Files 154, 31 mm, # 25, handle SMG |
| 07640142415954 | K-Files 154, 31 mm, # 20, handle SMG |
| 07640142415947 | K-Files 154, 31 mm, # 15, handle SMG |
| 07640142415930 | K-Files 154, 31 mm, # 10, handle SMG |
| 07640142415923 | K-Files 154, 31 mm, # 8, handle SMG |
| 07640142415916 | K-Files 154, 31 mm, # 6, handle SMG |
| 07640142415893 | K-Files 154, 25 mm, # 45-80, handle SMG |
| 07640142415886 | K-Files 154, 25 mm, # 15-40, handle SMG |
| 07640142415879 | K-Files 154, 25 mm, # 06-25, handle SMG |
| 07640142415848 | K-Files 154, 25 mm, # 80, handle SMG |
| 07640142415831 | K-Files 154, 25 mm, # 70, handle SMG |
| 07640142415824 | K-Files 154, 25 mm, # 60, handle SMG |
| 07640142415817 | K-Files 154, 25 mm, # 55, handle SMG |
| 07640142415800 | K-Files 154, 25 mm, # 50, handle SMG |
| 07640142415794 | K-Files 154, 25 mm, # 45, handle SMG |
| 07640142415787 | K-Files 154, 25 mm, # 40, handle SMG |
| 07640142415770 | K-Files 154, 25 mm, # 35, handle SMG |
| 07640142415763 | K-Files 154, 25 mm, # 30, handle SMG |
| 07640142415756 | K-Files 154, 25 mm, # 25, handle SMG |
| 07640142415749 | K-Files 154, 25 mm, # 20, handle SMG |
| 07640142415732 | K-Files 154, 25 mm, # 15, handle SMG |
| 07640142415725 | K-Files 154, 25 mm, # 10, handle SMG |
| 07640142415718 | K-Files 154, 25 mm, # 8, handle SMG |
| 07640142415701 | K-Files 154, 25 mm, # 6, handle SMG |
| 07640142415688 | K-Files 154, 21 mm, # 45-80, handle SMG |
| 07640142415671 | K-Files 154, 21 mm, # 15-40, handle SMG |
| 07640142415664 | K-Files 154, 21 mm, # 06-25, handle SMG |
| 07640142415657 | K-Files 154, 21 mm, # 80, handle SMG |
| 07640142415640 | K-Files 154, 21 mm, # 70, handle SMG |
| 07640142415633 | K-Files 154, 21 mm, # 60, handle SMG |
| 07640142415626 | K-Files 154, 21 mm, # 55, handle SMG |
| 07640142415619 | K-Files 154, 21 mm, # 50, handle SMG |
| 07640142415602 | K-Files 154, 21 mm, # 45, handle SMG |
| 07640142415596 | K-Files 154, 21 mm, # 40, handle SMG |
| 07640142415589 | K-Files 154, 21 mm, # 35, handle SMG |
| 07640142415572 | K-Files 154, 21 mm, # 30, handle SMG |
| 07640142415565 | K-Files 154, 21 mm, # 25, handle SMG |
| 07640142415558 | K-Files 154, 21 mm, # 20, handle SMG |