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Zirdent Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref HT-Plus 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 EUDAMEDHT-Plus EUDAMEDHT plus FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06975018580001 EUDAMEDFDA UDI
- Basic UDI-DI
- 697501858001K9 EUDAMED
- Direct Marketing DI
- 06975018580001 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 — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697501858001K9 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Zirdent New Material Co., Ltd.
- EUDAMED SRN
- CN-MF-000025335
- Authorised Representative
- Eunitor GmbH DE-AR-000005081
Sources (2)
- EUDAMED a9d84488-4fd8-49f0-84f9-f6b12f0cd84b 61 fields · synced Oct 6, 2026
- FDA UDI 5dd00127-ab0b-47c4-a4e4-2683ccb78562 33 fields · synced May 29, 2026