Dental Lithium Disilicate Glass Ceramics
by Liaoning Upcera Co Ltd 20 variants
Ref MD 0402 DentModel Dental Lithium Disilicate Glass Ceramic Block(CAD/CAM)
Active
CE MDR
Valid until
Not listed
FDA recalls
Not checked
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number694138229981J3 | Date8 Aug 2022 | StatusActive |
| United States | GUDID listing GUDID | Number06941382249745 | Date26 Mar 2019 | StatusListed |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade Name
- Dental Lithium Disilicate Glass Ceramics EUDAMEDDental Lithium Disilicate Glass Ceramic Block(Up.CAD Series) GUDID
- Generic Name
- Glass ionomer dental cement
- Model / Reference
- Dental Lithium Disilicate Glass Ceramic Block(CAD/CAM) EUDAMEDMD 0402 Dent EUDAMEDHT VBL2-R(18-15-13) GUDIDLT VBL4-R(18-15-13) GUDID
- Primary DI / UDI-DI
- 06941382249745, 06941382249523
- Basic UDI-DI
- 694138229981J3
- Direct Marketing DI
- 0694138224974506941382249523
- FDA Product Code
- EIH
- EMDN Code
- Q01020601 Mobile dental prostheses
- GMDN Term
- Glass ionomer dental cement
- Device Class
- Class IIa EUDAMEDClass II GUDID
- Regulation Number
- 872.6660
- EU market of registration
- Italy
- GUDID distribution status
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Model / Reference | Dental Lithium Disilicate Glass Ceramic Block(CAD/CAM) MD 0402 Dent | HT VBL2-R(18-15-13) LT VBL4-R(18-15-13) |
| Device Class | Class IIa | Class II |
Manufacturer details
- EUDAMED SRN
- CN-MF-000013088
- Authorised representative
- MedNet EC-REP GmbH DE-AR-000000002
Other devices from Liaoning Upcera Co., Ltd.
Properties
Other properties (20)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
- Prescription Use: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Serial Number: No