| Primary Device ID | 08806383537544 | 
| NIH Device Record Key | 510bd530-f3aa-4545-bfcb-a746dd7dfde5 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | H-FILES | 
| Version Model Number | 31m/m 35 | 
| Catalog Number | SS503-307 | 
| 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 | 08806383537544 [Primary] | 
| EKS | File, Pulp Canal, Endodontic | 
| Steralize Prior To Use | true | 
| Device Is Sterile | false | 
[08806383537544]
Moist Heat or Steam Sterilization
[08806383537544]
Moist Heat or Steam Sterilization
[08806383537544]
Moist Heat or Steam Sterilization
[08806383537544]
Moist Heat or Steam Sterilization
[08806383537544]
Moist Heat or Steam Sterilization
[08806383537544]
Moist Heat or Steam Sterilization
[08806383537544]
Moist Heat or Steam Sterilization
[08806383537544]
Moist Heat or Steam Sterilization
[08806383537544]
Moist Heat or Steam Sterilization
[08806383537544]
Moist Heat or Steam Sterilization
[08806383537544]
Moist Heat or Steam Sterilization
[08806383537544]
Moist Heat or Steam Sterilization
[08806383537544]
Moist Heat or Steam Sterilization
[08806383537544]
Moist Heat or Steam Sterilization
[08806383537544]
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 | 
| 08806383555487 | Files are mainly used to the preparation for various of dental pulp inflammation and dead dental | 
| 08806383555470 | Files are mainly used to the preparation for various of dental pulp inflammation and dead dental | 
| 08806383555401 | Files are mainly used to the preparation for various of dental pulp inflammation and dead dental | 
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| 08806383555319 | Files are mainly used to the preparation for various of dental pulp inflammation and dead dental | 
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| 08806383555296 | Files are mainly used to the preparation for various of dental pulp inflammation and dead dental | 
| 08806383555289 | Files are mainly used to the preparation for various of dental pulp inflammation and dead dental | 
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| 08806383555180 | Files are mainly used to the preparation for various of dental pulp inflammation and dead dental | 
| 08806383555173 | Files are mainly used to the preparation for various of dental pulp inflammation and dead dental | 
| 08806383553360 | Files are mainly used to the preparation for various of dental pulp inflammation and dead dental | 
| 08806383553353 | Files are mainly used to the preparation for various of dental pulp inflammation and dead dental | 
| 08806383553346 | Files are mainly used to the preparation for various of dental pulp inflammation and dead dental | 
| 08806383553339 | Files are mainly used to the preparation for various of dental pulp inflammation and dead dental | 
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| 08806383553193 | Files are mainly used to the preparation for various of dental pulp inflammation and dead dental | 
| 08806383553186 | Files are mainly used to the preparation for various of dental pulp inflammation and dead dental | 
| 08806383553179 | Files are mainly used to the preparation for various of dental pulp inflammation and dead dental | 
| 08806383553162 | Files are mainly used to the preparation for various of dental pulp inflammation and dead dental | 
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| 08806383553148 | Files are mainly used to the preparation for various of dental pulp inflammation and dead dental | 
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| 08806383537599 | Files are mainly used to the preparation for various of dental pulp inflammation and dead dental | 
| 08806383537582 | Files are mainly used to the preparation for various of dental pulp inflammation and dead dental | 
| 08806383537575 | Files are mainly used to the preparation for various of dental pulp inflammation and dead dental |