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Zirdent Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref ST Model HT-Plus, ST, ST-C, ST-ML, SHT, SHT-C, SHT-ML ,3D-Pro-ML,UT, UT-C,UT-ML
Identity
- Trade Name
- Zirdent Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank EUDAMEDFDA UDI
- Generic Name
- Dental appliance fabrication material, combination-material FDA UDI
- Device Name
- Zirdent Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank EUDAMED
- Model / Reference
- HT-Plus, ST, ST-C, ST-ML, SHT, SHT-C, SHT-ML ,3D-Pro-ML,UT, UT-C,UT-ML EUDAMEDST EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06975018580018 EUDAMEDFDA UDI
- Basic UDI-DI
- 697501858001K9 EUDAMED
- Direct Marketing DI
- 06975018580018 EUDAMED
- 510(k) Number
- K212259 FDA UDI
- FDA Product Code
- EIH FDA UDI
- EMDN Code
- Q010699 MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER EUDAMED
- GMDN Term
- Dental appliance fabrication material, combination-material FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.6660 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Zirdent Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank by Zirdent New Material Co., Ltd — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID…
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K212259 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 697501858001K9 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Zirdent New Material Co., Ltd.
- EUDAMED SRN
- CN-MF-000025335
- Authorised Representative
- Eunitor GmbH DE-AR-000005081
Sources (3)
- EUDAMED 8b186380-d19f-415c-91b4-b11a58040d2e 61 fields · synced Oct 6, 2026
- FDA UDI c613835b-43e1-4247-bc77-3afc5326b3c4 33 fields · synced May 29, 2026
- FDA 510(k) K212259 1 fields · synced May 18, 2026