Primary Device ID | 06970163084770 |
NIH Device Record Key | 06b76402-e0e6-46bc-b266-e09900cc010a |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Dentium® |
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 | 06970163084770 [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 |
06970163081878 - SHINING 3D® | 2024-05-07 The scanner is used to scan and capture the 3D characteristics of dental models including plaster models and impressions. It can |
06970163081885 - Adite® | 2024-05-07 The scanner is used to scan and capture the 3D characteristics of dental models including plaster models and impressions. It can |
06970163082103 - OPERA SYSTEM® | 2024-05-07 The scanner is used to scan and capture the 3D characteristics of dental models including plaster models and impressions. It can |
06970163081489 - MARATHON® | 2023-10-23 This is a 3D face scanner that works with the supplied software programs. By performing facial scanning directly, the scanner co |
06970163081229 - Opera System® | 2023-08-31 This is a 3D face scanner that works with the supplied software programs. By performing facial scanning directly, the scanner co |
06970163085043 - MARATHON® | 2023-08-31 The intraoral scanner uses an optical scanning method to directly collect 3D geometric data of the teeth and gums to be repaired |
06970163080635 - Zirkonzahn® | 2023-08-24 The intraoral scanner uses an optical scanning method to directly collect 3D geometric data of the teeth and gums to be repaired |
06970163086118 - cameo™ | 2023-08-24 The intraoral scanner uses an optical scanning method to directly collect 3D geometric data of the teeth and gums to be repaired |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
DENTIUM 79047889 3534329 Live/Registered |
DENTIUM CO., LTD. 2007-08-02 |
DENTIUM 76483335 not registered Dead/Abandoned |
SABINI, ARMAN 2003-01-15 |