| Primary Device ID | 06947600309123 |
| NIH Device Record Key | e3de15b3-d966-4801-89da-8687bd51be49 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TLRN Digital Analog |
| Version Model Number | 062220 |
| Company DUNS | 527603266 |
| Company Name | BIO CONCEPT 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 | 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 | 06947600309123 [Primary] |
| NDP | Accessories, Implant, Dental, Endosseous |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-11-29 |
| Device Publish Date | 2024-11-21 |
| 06947600309055 - Scanbody for screw-retained abutment | 2024-11-29 |
| 06947600309079 - Scanbody for screw-retained abutment | 2024-11-29 |
| 06947600309109 - BLNC Digital Analog | 2024-11-29 |
| 06947600309116 - BLRC Digital Analog | 2024-11-29 |
| 06947600309123 - TLRN Digital Analog | 2024-11-29 |
| 06947600309123 - TLRN Digital Analog | 2024-11-29 |
| 06947600309130 - TLWN Digital Analog | 2024-11-29 |
| 06947600309147 - BL3.5 Screw-retained Abutment Digital Analog | 2024-11-29 |
| 06947600309154 - BL4.6 Screw-retained Abutment Digital Analog | 2024-11-29 |