Opera System®
GUDID 06970163085135
The intraoral scanner uses an optical scanning method to directly collect 3D geometric data of the teeth and gums to be repaired in the patient's mouth, and provides 3D digital models for CAD/CAM denture design and processing.
Shining 3D Tech Co., Ltd.
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| NIH Device Record Key | 47ae8c02-3399-4dc4-9e46-63202fb3e270 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Opera System® |
| Version Model Number | Aoralscan 3 Wireless |
| 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 | 06970163085135 [Primary] |
FDA Product Code
| NOF | System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[06970163085135]
Moist Heat or Steam Sterilization
[06970163085135]
Moist Heat or Steam Sterilization
[06970163085135]
Moist Heat or Steam Sterilization
[06970163085135]
Moist Heat or Steam Sterilization
[06970163085135]
Moist Heat or Steam Sterilization
[06970163085135]
Moist Heat or Steam Sterilization
[06970163085135]
Moist Heat or Steam Sterilization
[06970163085135]
Moist Heat or Steam Sterilization
[06970163085135]
Moist Heat or Steam Sterilization
[06970163085135]
Moist Heat or Steam Sterilization
[06970163085135]
Moist Heat or Steam Sterilization
[06970163085135]
Moist Heat or Steam Sterilization
[06970163085135]
Moist Heat or Steam Sterilization
[06970163085135]
Moist Heat or Steam Sterilization
[06970163085135]
Moist Heat or Steam Sterilization
[06970163085135]
Moist Heat or Steam Sterilization
[06970163085135]
Moist Heat or Steam Sterilization
[06970163085135]
Moist Heat or Steam Sterilization
[06970163085135]
Moist Heat or Steam Sterilization
[06970163085135]
Moist Heat or Steam Sterilization
[06970163085135]
Moist Heat or Steam Sterilization
[06970163085135]
Moist Heat or Steam Sterilization
[06970163085135]
Moist Heat or Steam Sterilization
[06970163085135]
Moist Heat or Steam Sterilization
[06970163085135]
Moist Heat or Steam Sterilization
[06970163085135]
Moist Heat or Steam Sterilization
[06970163085135]
Moist Heat or Steam Sterilization
[06970163085135]
Moist Heat or Steam Sterilization
[06970163085135]
Moist Heat or Steam Sterilization
[06970163085135]
Moist Heat or Steam Sterilization
[06970163085135]
Moist Heat or Steam Sterilization
[06970163085135]
Moist Heat or Steam Sterilization
[06970163085135]
Moist Heat or Steam Sterilization
[06970163085135]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-08-14 |
| Device Publish Date | 2023-08-04 |
On-Brand Devices [Opera System®]
| 06970163082691 | The intraoral scanner uses an optical scanning method to directly collect 3D geometric data of t |
| 06970163080512 | The intraoral scanner uses an optical scanning method to directly collect 3D geometric data of t |
| 06970163085135 | The intraoral scanner uses an optical scanning method to directly collect 3D geometric data of t |
| 06970163081229 | This is a 3D face scanner that works with the supplied software programs. By performing facial s |
| 06970163082103 | The scanner is used to scan and capture the 3D characteristics of dental models including plaste |
Trademark Results [Opera System]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 OPERA SYSTEM 75382684 not registered Dead/Abandoned |
FemRx, Inc. 1997-10-30 |
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