| Primary Device ID | 09359215000215 |
| NIH Device Record Key | 9bad9ad1-a5a0-405a-87fc-6414a504a214 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DentaTRY B3 |
| Version Model Number | 03825 |
| Company DUNS | 745954045 |
| Company Name | ASIGA PTY 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 | false |
| 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 | 09359215000215 [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 | 2024-02-14 |
| Device Publish Date | 2024-02-06 |
| 09359215000109 - DentaTOOTH | 2025-05-20 DentaTOOTH is a resin material used by dental professionals for the manufacture of temporary dental restorations including tempo |
| 09359215000369 - DentaBASE | 2025-04-25 Asiga DentaBASE resins are used with digital light processing (DLP) based 3D printers to produce denture bases. DentaBASE resin |
| 09359215000031 - DentaGUIDE | 2024-02-14 |
| 09359215000055 - DentaIBT | 2024-02-14 |
| 09359215000093 - DentaTRAY | 2024-02-14 |
| 09359215000161 - DentaTRY A1 | 2024-02-14 |
| 09359215000178 - DentaTRY A2 | 2024-02-14 |
| 09359215000185 - DentaTRY A3 | 2024-02-14 |