| Primary Device ID | 06970163084916 |
| NIH Device Record Key | 9b0b9795-700f-4c4f-82aa-e195e82afb3c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | LARGEV® |
| Version Model Number | Aoralscan 2 |
| 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 | 06970163084916 [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 |
| 06970163083063 - SHINING 3D® | 2024-11-05 |
| 06970163083056 - SHINING 3D® | 2024-11-04 |
| 06970163083094 - SHINING 3D® | 2024-11-04 |
| 06970163083100 - SHINING 3D® | 2024-11-04 |
| 06970163083032 - SHINING 3D® | 2024-10-21 The intraoral scanner uses an optical scanning method to directly collect 3D geometric data of the teeth and gums to be repaired |
| 06970163081083 - cameo™ | 2024-08-06 |
| 06970163081090 - cameo™ | 2024-08-06 |
| 06970163082684 - SHINING3D® | 2024-08-01 |