| Primary Device ID | 08806383536530 | 
| NIH Device Record Key | 495832d3-f3cc-4f26-aa08-25977ad7d1f1 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | K-FILES | 
| Version Model Number | 21m/m ASST 15/40 | 
| Catalog Number | SS502-191 | 
| 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 | false | 
| 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 | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 08806383536530 [Primary] | 
| EKS | File, Pulp Canal, Endodontic | 
| Steralize Prior To Use | true | 
| Device Is Sterile | false | 
[08806383536530]
Moist Heat or Steam Sterilization
[08806383536530]
Moist Heat or Steam Sterilization
[08806383536530]
Moist Heat or Steam Sterilization
[08806383536530]
Moist Heat or Steam Sterilization
[08806383536530]
Moist Heat or Steam Sterilization
[08806383536530]
Moist Heat or Steam Sterilization
[08806383536530]
Moist Heat or Steam Sterilization
[08806383536530]
Moist Heat or Steam Sterilization
[08806383536530]
Moist Heat or Steam Sterilization
[08806383536530]
Moist Heat or Steam Sterilization
[08806383536530]
Moist Heat or Steam Sterilization
[08806383536530]
Moist Heat or Steam Sterilization
[08806383536530]
Moist Heat or Steam Sterilization
[08806383536530]
Moist Heat or Steam Sterilization
[08806383536530]
Moist Heat or Steam Sterilization
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2020-06-17 | 
| Device Publish Date | 2020-06-09 | 
| 08806383554961 | Files are mainly used to the preparation for various of dental pulp inflammation and dead dental | 
| 08806383554954 | Files are mainly used to the preparation for various of dental pulp inflammation and dead dental | 
| 08806383536752 | Files are mainly used to the preparation for various of dental pulp inflammation and dead dental | 
| 08806383536745 | Files are mainly used to the preparation for various of dental pulp inflammation and dead dental | 
| 08806383536738 | Files are mainly used to the preparation for various of dental pulp inflammation and dead dental | 
| 08806383536721 | Files are mainly used to the preparation for various of dental pulp inflammation and dead dental | 
| 08806383536714 | Files are mainly used to the preparation for various of dental pulp inflammation and dead dental | 
| 08806383536684 | Files are mainly used to the preparation for various of dental pulp inflammation and dead dental | 
| 08806383536677 | Files are mainly used to the preparation for various of dental pulp inflammation and dead dental | 
| 08806383536660 | Files are mainly used to the preparation for various of dental pulp inflammation and dead dental | 
| 08806383536653 | Files are mainly used to the preparation for various of dental pulp inflammation and dead dental | 
| 08806383536646 | Files are mainly used to the preparation for various of dental pulp inflammation and dead dental | 
| 08806383536639 | Files are mainly used to the preparation for various of dental pulp inflammation and dead dental | 
| 08806383536622 | Files are mainly used to the preparation for various of dental pulp inflammation and dead dental | 
| 08806383536615 | Files are mainly used to the preparation for various of dental pulp inflammation and dead dental | 
| 08806383536608 | Files are mainly used to the preparation for various of dental pulp inflammation and dead dental | 
| 08806383536592 | Files are mainly used to the preparation for various of dental pulp inflammation and dead dental | 
| 08806383536585 | Files are mainly used to the preparation for various of dental pulp inflammation and dead dental | 
| 08806383536578 | Files are mainly used to the preparation for various of dental pulp inflammation and dead dental | 
| 08806383536561 | Files are mainly used to the preparation for various of dental pulp inflammation and dead dental | 
| 08806383536554 | Files are mainly used to the preparation for various of dental pulp inflammation and dead dental | 
| 08806383536547 | Files are mainly used to the preparation for various of dental pulp inflammation and dead dental | 
| 08806383536530 | Files are mainly used to the preparation for various of dental pulp inflammation and dead dental | 
| 08806383536523 | Files are mainly used to the preparation for various of dental pulp inflammation and dead dental | 
| 08806383536516 | Files are mainly used to the preparation for various of dental pulp inflammation and dead dental | 
| 08806383536509 | Files are mainly used to the preparation for various of dental pulp inflammation and dead dental | 
| 08806383536493 | Files are mainly used to the preparation for various of dental pulp inflammation and dead dental | 
| 08806383536486 | Files are mainly used to the preparation for various of dental pulp inflammation and dead dental | 
| 08806383536479 | Files are mainly used to the preparation for various of dental pulp inflammation and dead dental | 
| 08806383536462 | Files are mainly used to the preparation for various of dental pulp inflammation and dead dental | 
| 08806383536455 | Files are mainly used to the preparation for various of dental pulp inflammation and dead dental | 
| 08806383536448 | Files are mainly used to the preparation for various of dental pulp inflammation and dead dental | 
| 08806383536431 | Files are mainly used to the preparation for various of dental pulp inflammation and dead dental | 
| 08806383536424 | Files are mainly used to the preparation for various of dental pulp inflammation and dead dental | 
| 08806383536417 | Files are mainly used to the preparation for various of dental pulp inflammation and dead dental | 
| 08806383536400 | Files are mainly used to the preparation for various of dental pulp inflammation and dead dental | 
| 08806383536394 | Files are mainly used to the preparation for various of dental pulp inflammation and dead dental | 
| 08806383536387 | Files are mainly used to the preparation for various of dental pulp inflammation and dead dental | 
| 08806383536370 | Files are mainly used to the preparation for various of dental pulp inflammation and dead dental | 
| 08806383536363 | Files are mainly used to the preparation for various of dental pulp inflammation and dead dental | 
| 08806383536356 | Files are mainly used to the preparation for various of dental pulp inflammation and dead dental | 
| 08806383536349 | Files are mainly used to the preparation for various of dental pulp inflammation and dead dental | 
| 08806383536332 | Files are mainly used to the preparation for various of dental pulp inflammation and dead dental |