| Primary Device ID | 08806383552127 |
| NIH Device Record Key | 8d097ddc-1d8f-4803-9cdc-a9f88ea32338 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | K-FILES (Nickel-Titanium) |
| Version Model Number | 31m/m 55 |
| Catalog Number | NT502-311 |
| 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 | 08806383552127 [Primary] |
| EKS | File, Pulp Canal, Endodontic |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08806383552127]
Moist Heat or Steam Sterilization
[08806383552127]
Moist Heat or Steam Sterilization
[08806383552127]
Moist Heat or Steam Sterilization
[08806383552127]
Moist Heat or Steam Sterilization
[08806383552127]
Moist Heat or Steam Sterilization
[08806383552127]
Moist Heat or Steam Sterilization
[08806383552127]
Moist Heat or Steam Sterilization
[08806383552127]
Moist Heat or Steam Sterilization
[08806383552127]
Moist Heat or Steam Sterilization
[08806383552127]
Moist Heat or Steam Sterilization
[08806383552127]
Moist Heat or Steam Sterilization
[08806383552127]
Moist Heat or Steam Sterilization
[08806383552127]
Moist Heat or Steam Sterilization
[08806383552127]
Moist Heat or Steam Sterilization
[08806383552127]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-06-23 |
| Device Publish Date | 2020-06-15 |
| 08806383552165 | Files are mainly used to the preparation for various of dental pulp inflammation and dead dental |
| 08806383552158 | Files are mainly used to the preparation for various of dental pulp inflammation and dead dental |
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| 08806383552127 | Files are mainly used to the preparation for various of dental pulp inflammation and dead dental |
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