| Primary Device ID | 06970163084930 |
| NIH Device Record Key | 2b9da185-8094-435c-a557-91e912b67b48 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ThunPure™ |
| Version Model Number | Aoralscan ThunPure |
| Company DUNS | 529835314 |
| Company Name | Shining 3D Tech 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 | false |
| Lot Batch | false |
| 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 | 06970163084930 [Primary] |
| NOF | System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-04-02 |
| Device Publish Date | 2021-03-25 |
| 06970163089546 - SHINING 3D® | 2026-02-09 The intraoral scanner uses an optical scanning method to directly collect 3D geometric data of the teeth and gums to be repaired |
| 06970163089553 - SHINING 3D® | 2026-02-09 |
| 06970163089560 - SHINING 3D® | 2026-02-09 |
| 06970163089577 - SHINING 3D® | 2026-02-09 |
| 06970163089416 - SHINING 3D® | 2026-01-09 |
| 06970163089430 - SHINING 3D® | 2026-01-09 |
| 06970163089447 - SHINING 3D® | 2026-01-09 |
| 06970163089454 - SHINING 3D® | 2026-01-09 |