MIISEN®
GUDID 06975801801177
Dental Zirconia Block (Model: HTplus, ST, SHT,UT, 3D-Pro) is intended for use with CAD/CAM technology to produce all ceramic dental restorations as prescibed by a dentist. All blanks are processed through dental laboratories or by dental professionals.
Anhui Miisen Intelligence Technology Co., Ltd.
Dental appliance fabrication material, ceramic| Primary Device ID | 06975801801177 |
| NIH Device Record Key | 030cfc1c-0fa8-45fa-bfc9-1fa9c9149b00 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MIISEN® |
| Version Model Number | 3D-Pro ML-BL1 98*20 |
| Company DUNS | 406697046 |
| Company Name | Anhui Miisen Intelligence Technology Co., Ltd. |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| 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 | 06975801801177 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K240912
FDA Product Code
| EIH | Powder, Porcelain |
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 | 2024-11-11 |
| Device Publish Date | 2024-11-01 |
On-Brand Devices [MIISEN®]
| 06975801800026 | Dental Zirconia Block (Model: HT-plus, ST, SHT, UT, 3D-Pro)” is Intended for use with CAD/CAM |
| 06975801800019 | Dental Zirconia Block (Model: HT-plus, ST, SHT, UT, 3D-Pro)” is Intended for use with CAD/CAM |
| 06975801801078 | Dental Zirconia Block (Model: HTplus, ST, SHT,UT, 3D-Pro) is intended for use with CAD/CAM techn |
| 06975801801061 | Dental Zirconia Block (Model: HTplus, ST, SHT,UT, 3D-Pro) is intended for use with CAD/CAM techn |
| 06975801801054 | Dental Zirconia Block (Model: HTplus, ST, SHT,UT, 3D-Pro) is intended for use with CAD/CAM techn |
| 06975801801030 | Dental Zirconia Block (Model: HTplus, ST, SHT,UT, 3D-Pro) is intended for use with CAD/CAM techn |
| 06975801801023 | Dental Zirconia Block (Model: HTplus, ST, SHT,UT, 3D-Pro) is intended for use with CAD/CAM techn |
| 06975801801016 | Dental Zirconia Block (Model: HTplus, ST, SHT,UT, 3D-Pro) is intended for use with CAD/CAM techn |
| 06975801800798 | Dental Zirconia Block (Model: HTplus, ST, SHT,UT, 3D-Pro) is intended for use with CAD/CAM techn |
| 06975801800781 | Dental Zirconia Block (Model: HTplus, ST, SHT,UT, 3D-Pro) is intended for use with CAD/CAM techn |
| 06975801800774 | Dental Zirconia Block (Model: HTplus, ST, SHT,UT, 3D-Pro) is intended for use with CAD/CAM techn |
| 06975801800750 | Dental Zirconia Block (Model: HTplus, ST, SHT,UT, 3D-Pro) is intended for use with CAD/CAM techn |
| 06975801800743 | Dental Zirconia Block (Model: HTplus, ST, SHT,UT, 3D-Pro) is intended for use with CAD/CAM techn |
| 06975801800712 | Dental Zirconia Block (Model: HTplus, ST, SHT,UT, 3D-Pro) is intended for use with CAD/CAM techn |
| 06975801800675 | Dental Zirconia Block (Model: HTplus, ST, SHT,UT, 3D-Pro) is intended for use with CAD/CAM techn |
| 06975801800668 | Dental Zirconia Block (Model: HTplus, ST, SHT,UT, 3D-Pro) is intended for use with CAD/CAM techn |
| 06975801800644 | Dental Zirconia Block (Model: HTplus, ST, SHT,UT, 3D-Pro) is intended for use with CAD/CAM techn |
| 06975801800637 | Dental Zirconia Block (Model: HTplus, ST, SHT,UT, 3D-Pro) is intended for use with CAD/CAM techn |
| 06975801800620 | Dental Zirconia Block (Model: HTplus, ST, SHT,UT, 3D-Pro) is intended for use with CAD/CAM techn |
| 06975801800613 | Dental Zirconia Block (Model: HTplus, ST, SHT,UT, 3D-Pro) is intended for use with CAD/CAM techn |
| 06975801801436 | Dental Zirconia Block (Model: HTplus, ST, SHT,UT, 3D-Pro) is intended for use with CAD/CAM techn |
| 06975801801429 | Dental Zirconia Block (Model: HTplus, ST, SHT,UT, 3D-Pro) is intended for use with CAD/CAM techn |
| 06975801801207 | Dental Zirconia Block (Model: HTplus, ST, SHT,UT, 3D-Pro) is intended for use with CAD/CAM techn |
| 06975801801191 | Dental Zirconia Block (Model: HTplus, ST, SHT,UT, 3D-Pro) is intended for use with CAD/CAM techn |
| 06975801801184 | Dental Zirconia Block (Model: HTplus, ST, SHT,UT, 3D-Pro) is intended for use with CAD/CAM techn |
| 06975801801177 | Dental Zirconia Block (Model: HTplus, ST, SHT,UT, 3D-Pro) is intended for use with CAD/CAM techn |
| 06975801801153 | Dental Zirconia Block (Model: HTplus, ST, SHT,UT, 3D-Pro) is intended for use with CAD/CAM techn |
| 06975801807933 | Dental Zirconia Block (Model: HTplus, ST, SHT,UT, 3D-Pro) is intended for use with CAD/CAM techn |
| 06975801807926 | Dental Zirconia Block (Model: HTplus, ST, SHT,UT, 3D-Pro) is intended for use with CAD/CAM techn |
| 06975801807919 | Dental Zirconia Block (Model: HTplus, ST, SHT,UT, 3D-Pro) is intended for use with CAD/CAM techn |
| 06975801807902 | Dental Zirconia Block (Model: HTplus, ST, SHT,UT, 3D-Pro) is intended for use with CAD/CAM techn |
| 06975801807896 | Dental Zirconia Block (Model: HTplus, ST, SHT,UT, 3D-Pro) is intended for use with CAD/CAM techn |
| 06975801807889 | Dental Zirconia Block (Model: HTplus, ST, SHT,UT, 3D-Pro) is intended for use with CAD/CAM techn |
Trademark Results [MIISEN]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MIISEN 79386258 not registered Live/Pending |
Anhui Miisen Intelligence Technology Co., Ltd. 2023-08-17 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.