| Primary Device ID | 06972902588112 |
| NIH Device Record Key | dbbf7811-9a27-486d-8776-3d73c44c2497 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | C-Root |
| Version Model Number | 015/08 19mm |
| Catalog Number | file 015/08 19mm |
| Company DUNS | 415018580 |
| Company Name | Beijing C-Root Dental Medical Devices Co., LTD. |
| 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 | true |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | true |
| 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 | 06972902588112 [Primary] |
| GS1 | 16972902588119 [Package] Package: box [10 Units] In Commercial Distribution |
| GS1 | 26972902588116 [Package] Contains: 16972902588119 Package: carton [75 Units] In Commercial Distribution |
| EKS | File, Pulp Canal, Endodontic |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[06972902588112]
Moist Heat or Steam Sterilization
[06972902588112]
Moist Heat or Steam Sterilization
[06972902588112]
Moist Heat or Steam Sterilization
[06972902588112]
Moist Heat or Steam Sterilization
[06972902588112]
Moist Heat or Steam Sterilization
[06972902588112]
Moist Heat or Steam Sterilization
[06972902588112]
Moist Heat or Steam Sterilization
[06972902588112]
Moist Heat or Steam Sterilization
[06972902588112]
Moist Heat or Steam Sterilization
[06972902588112]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-06-16 |
| Device Publish Date | 2025-06-08 |
| 16972902583398 | 2g |
| 16972902583282 | 1g |
| 06972902583223 | 04 |
| 06972902583216 | 06 |
| 06972902583773 | 150325, etc |
| 06972902583605 | 06-25 |
| 06972902583568 | 04-25 |
| 06972902583063 | C-Root Caulking Putty Paste is specially designed, cellulose-based caulking and block-out materi |
| 06972902581861 | 0.5g |
| 06972902582288 | 6g |
| 06972902583728 | 2g |
| 06972902583711 | 1g |
| 06972902581663 | 0.5g |
| 06972902583537 | 1 |
| 06972902588112 | 015/08 19mm |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() C-ROOT 97935232 not registered Live/Pending |
C-ROOT DENTAL USA CORPORATION 2023-05-13 |