Glaze paste PA-OM3
Ref /Model Glaze Paste
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 | Number694138229991J6 06941382254503 | Date23 Apr 2023 | StatusActive |
| United States | GUDID listing GUDID | Number06941382254503 | Date24 May 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- Withdrawn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
- Glaze paste
- Generic Name
- Dental porcelain/ceramic restoration kit
- Model / Reference
- Glaze Paste EUDAMED/ EUDAMEDPA-OM3 GUDID
- Primary DI / UDI-DI
- 06941382254503
- Basic UDI-DI
- 694138229991J6
- Direct Marketing DI
- 06941382254503
- FDA Product Code
- EIH
- EMDN Code
- Q01010199 Dental restoration devices - other
- GMDN Term
- Dental porcelain/ceramic restoration kit
- Device Class
- Class IIa EUDAMEDClass II GUDID
- Regulation Number
- 872.6660
- EU market of registration
- Croatia
- GUDID distribution status
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Model / Reference | Glaze Paste / | PA-OM3 |
| Device Class | Class IIa | Class II |
| Implantable | Yes | No |
Other devices from Liaoning Upcera Co., Ltd.
Properties
Other properties (19)
- Sterile: 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