Vitapan® Lingoform Dd Frame
by VITA Zahnfabrik H. Rauter GmbH & Co. KG 48 variants
Ref AGA322LU
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 | Number++J017AA1PE | Date3 Jul 2024 | StatusActive |
| United States | GUDID listing GUDID | NumberJ017AGA322LU0 | Date27 Feb 2020 | 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- Withdrawn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
- Vitapan® Lingoform Dd Frame EUDAMEDVita Lingoform GUDID
- Generic Name
- Resin artificial teeth
- Device Name
- Artificial teeth
- Model / Reference
- AGA322LU
- Primary DI / UDI-DI
- J017AGA322LU0
- Basic UDI-DI
- ++J017AA1PE
- 510(k) Number
- FDA Product Code
- ELM
- EMDN Code
- Q010699 Materials for the preparation of custom-made dental devices - other
- GMDN Term
- Resin artificial teeth
- Device Class
- Class IIa EUDAMEDClass II GUDID
- Regulation Number
- 872.3590
- Market of Registration
- Germany
- GUDID distribution status
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device Class | Class IIa | Class II |
Manufacturer details
- EUDAMED SRN
- DE-MF-000005906
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Properties
Other properties (22)
- Sterile: No
- Single Use: 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
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Lot / Batch Number: No
- Serial Number: No
- Expiration Date: No