Adite®
GUDID 06970163081885
The scanner is used to scan and capture the 3D characteristics of dental models including plaster models and impressions. It can work with the supplied software to export the 3D scan data for CAD/CAM. the scan data can be apply for the orthodontic, restoration and implant.
Shining 3D Tech Co., Ltd.
Dental milling system, CAD/CAM, laboratory| Primary Device ID | 06970163081885 |
| NIH Device Record Key | 75edf2aa-c5cc-49f3-9ee5-5aafb716a0de |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Adite® |
| Version Model Number | A-IS Pro3 |
| 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 | false |
| OTC Over-The-Counter | false |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06970163081885 [Primary] |
FDA Product Code
| NOF | System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-05-07 |
| Device Publish Date | 2024-04-29 |
Devices Manufactured by Shining 3D Tech Co., Ltd.
| 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 |
Trademark Results [Adite]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ADITE 76376345 2651963 Dead/Cancelled |
GLASSER, KENNETH 2002-02-27 |
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