DD base P HI 98H30 gingiva 3
Ref K50830
Active
CE MDR
Valid until
Not listed
FDA recalls
None foundDocuments
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number++EDDIPOLYMER1209IIARC EDDIK508301 | Date10 Jul 2026 | StatusActive |
| United States | GUDID listing GUDID | NumberEDDIK508301 | Date27 Jul 2023 | StatusListed |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Recalls
No FDA recalls found in the data synced 25 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade Name
- DD base P HI 98H30 gingiva 3 EUDAMEDDD base P HI GUDID
- Generic Name
- Dental appliance fabrication material, thermoplastic
- Device Name
- DD medical polymers 1209
- Model / Ref / Catalog
- K50830, 98H30 gingiva 3
- Primary DI / UDI-DI
- EDDIK508301
- Basic UDI-DI
- ++EDDIPOLYMER1209IIARC
- 510(k) Number
- FDA Product Code
- EBI
- EMDN Code
- Q010699 Materials for the preparation of custom-made dental devices - other
- GMDN Term
- Dental appliance fabrication material, thermoplastic
- Device Class
- Class IIa EUDAMEDClass II GUDID
- Regulation Number
- 872.3760
- GUDID distribution status
- In Commercial Distribution
- Size
- Height — 30 MillimeterOuter Diameter — 98.5 Millimeter
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Model / Reference | K50830 | 98H30 gingiva 3 |
| Device Class | Class IIa | Class II |
Other devices from Dental Direkt GmbH
Properties
Other properties (19)
- 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
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Serial Number: No