INTELLISCAN 3D® Intraoral Scanner
GUDID 06970163081458
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 | c9360971-8de8-466f-93a7-d8820c1a871e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | INTELLISCAN 3D® Intraoral Scanner |
| Version Model Number | Intelliscan 3X |
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06970163081458 [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 |
[06970163081458]
Moist Heat or Steam Sterilization
[06970163081458]
Moist Heat or Steam Sterilization
[06970163081458]
Moist Heat or Steam Sterilization
[06970163081458]
Moist Heat or Steam Sterilization
[06970163081458]
Moist Heat or Steam Sterilization
[06970163081458]
Moist Heat or Steam Sterilization
[06970163081458]
Moist Heat or Steam Sterilization
[06970163081458]
Moist Heat or Steam Sterilization
[06970163081458]
Moist Heat or Steam Sterilization
[06970163081458]
Moist Heat or Steam Sterilization
[06970163081458]
Moist Heat or Steam Sterilization
[06970163081458]
Moist Heat or Steam Sterilization
[06970163081458]
Moist Heat or Steam Sterilization
[06970163081458]
Moist Heat or Steam Sterilization
[06970163081458]
Moist Heat or Steam Sterilization
[06970163081458]
Moist Heat or Steam Sterilization
[06970163081458]
Moist Heat or Steam Sterilization
[06970163081458]
Moist Heat or Steam Sterilization
[06970163081458]
Moist Heat or Steam Sterilization
[06970163081458]
Moist Heat or Steam Sterilization
[06970163081458]
Moist Heat or Steam Sterilization
[06970163081458]
Moist Heat or Steam Sterilization
[06970163081458]
Moist Heat or Steam Sterilization
[06970163081458]
Moist Heat or Steam Sterilization
[06970163081458]
Moist Heat or Steam Sterilization
[06970163081458]
Moist Heat or Steam Sterilization
[06970163081458]
Moist Heat or Steam Sterilization
[06970163081458]
Moist Heat or Steam Sterilization
[06970163081458]
Moist Heat or Steam Sterilization
[06970163081458]
Moist Heat or Steam Sterilization
[06970163081458]
Moist Heat or Steam Sterilization
[06970163081458]
Moist Heat or Steam Sterilization
[06970163081458]
Moist Heat or Steam Sterilization
[06970163081458]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-11-04 |
| Device Publish Date | 2021-10-27 |
On-Brand Devices [INTELLISCAN 3D® Intraoral Scanner]
| 06970163080024 | The intraoral scanner uses an optical scanning method to directly collect 3D geometric data of t |
| 06970163083568 | The intraoral scanner uses an optical scanning method to directly collect 3D geometric data of t |
| 06970163081458 | The intraoral scanner uses an optical scanning method to directly collect 3D geometric data of t |
Trademark Results [INTELLISCAN 3D]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 INTELLISCAN 3D 86771680 5247016 Live/Registered |
Bayshore Dental Studio Llc 2015-09-29 |
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