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Zirking
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref N/AModel High Translucency (HT), Anterior Translucency (AT), High Strength (HS), Multi-layered High Translucency (MHT), High Translucency Plus (HT PLUS), Gradient Multilayer (GM), MaxMultilayer-4D (MM-4D)Ref Gradient Multilayer(GM)/98×20mm/C2-3D/1*1Ref Gradient Multilayer(GM)/98×20mm/A2-3D/1*1Ref Gradient Multilayer(GM)/98×16mm/C2-3D/1*1Ref Gradient Multilayer(GM)/98×16mm/A2-3D/1*1Ref Gradient Multilayer(GM)/98×16mm/A1-3D/1*1Ref Multi-layered High Translucency(MHT)/98×16mm/A1/1*1Model High Translucency (HT), Anterior Translucency (AT), High Strength (HS), Multi-layered High Translucency (MHT), High Translucency Plus (HT PLUS), Gradient Multilayer (GM), MaxMultilayer-4D (MM-4D), Anterior Translucency Multilayer (ATML)Ref Multi-layered High Translucency(MHT)/95×10mm/BL1/1*1Ref Gradient Multilayer(GM)/95×14mm/A2-3D/1*1Ref MaxMultilayer-4D(MM-4D)/95×16mm/5M1/1*1Ref High Translucency(HT)/98×22mm/C4/1*1Ref High Translucency Plus(HT PLUS)/98×30mm/C1/1*1Ref MaxMultilayer-4D(MM-4D)/98×30mm/C2/1*1Ref Anterior Translucency(AT)/98×16mm/B2/1*1Ref High Translucency Plus(HT PLUS)/98×22mm/A1/1*1Ref Anterior Translucency(AT)/95×20mm/B2/1*1Ref High Translucency(HT)/89×71×16mm/C4/1*1Ref MaxMultilayer-4D(MM-4D)/95×10mm/D3/1*1Ref High Translucency Plus(HT PLUS)/98×10mm/A1/1*1Ref Multi-layered High Translucency(MHT)/98×20mm/BL3/1*1Ref MaxMultilayer-4D(MM-4D)/89×71×16mm/3M1/1*1Ref Gradient Multilayer(GM)/98×16mm/A3.5-3D/1*1Ref MaxMultilayer-4D(MM-4D)/98×20mm/5M1/1*1Ref MaxMultilayer-4D(MM-4D)/98×10mm/2L1.5/1*1Ref Anterior Translucency(AT)/95×12mm/BL2/1*1
Identity
- Trade Name
- Zirking EUDAMEDZirconia Block EUDAMEDFDA UDI
- Generic Name
- Dental appliance fabrication material, ceramic FDA UDI
- Device Name
- Zirconia Block EUDAMED
- Model / Reference
- High Translucency (HT), Anterior Translucency (AT), High Strength (HS), Multi-layered High Translucency (MHT), High Translucency Plus (HT PLUS), Gradient Multilayer (GM), MaxMultilayer-4D (MM-4D) EUDAMEDN/A EUDAMEDGradient Multilayer(GM)/98×20mm/C2-3D/1*1 EUDAMEDGradient Multilayer(GM)/98×20mm/A2-3D/1*1 EUDAMEDGradient Multilayer(GM)/98×16mm/C2-3D/1*1 EUDAMEDGradient Multilayer(GM)/98×16mm/A2-3D/1*1 EUDAMEDGradient Multilayer(GM)/98×16mm/A1-3D/1*1 EUDAMEDHigh Translucency (HT), Anterior Translucency (AT), High Strength (HS), Multi-layered High Translucency (MHT), High Translucency Plus (HT PLUS), Gradient Multilayer (GM), MaxMultilayer-4D (MM-4D), Anterior Translucency Multilayer (ATML) EUDAMEDMulti-layered High Translucency(MHT)/98×16mm/A1/1*1 EUDAMEDMulti-layered High Translucency(MHT)/95×10mm/BL1/1*1 EUDAMEDGradient Multilayer(GM)/95×14mm/A2-3D/1*1 EUDAMEDMaxMultilayer-4D(MM-4D)/95×16mm/5M1/1*1 EUDAMEDHigh Translucency(HT)/98×22mm/C4/1*1 EUDAMEDHigh Translucency Plus(HT PLUS)/98×30mm/C1/1*1 EUDAMEDMaxMultilayer-4D(MM-4D)/98×30mm/C2/1*1 EUDAMEDAnterior Translucency(AT)/98×16mm/B2/1*1 EUDAMEDHigh Translucency Plus(HT PLUS)/98×22mm/A1/1*1 EUDAMEDAnterior Translucency(AT)/95×20mm/B2/1*1 EUDAMEDHigh Translucency(HT)/89×71×16mm/C4/1*1 EUDAMEDMaxMultilayer-4D(MM-4D)/95×10mm/D3/1*1 EUDAMEDHigh Translucency Plus(HT PLUS)/98×10mm/A1/1*1 EUDAMEDMulti-layered High Translucency(MHT)/98×20mm/BL3/1*1 EUDAMEDMaxMultilayer-4D(MM-4D)/89×71×16mm/3M1/1*1 EUDAMEDGradient Multilayer(GM)/98×16mm/A3.5-3D/1*1 EUDAMEDMaxMultilayer-4D(MM-4D)/98×20mm/5M1/1*1 EUDAMEDMaxMultilayer-4D(MM-4D)/98×10mm/2L1.5/1*1 EUDAMEDAnterior Translucency(AT)/95×12mm/BL2/1*1 EUDAMEDHT FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06909412123410 EUDAMED06909412123427 EUDAMED06909412168428 EUDAMED06909412168305 EUDAMED06909412123519 EUDAMED06909412169593 EUDAMED06909412336490 EUDAMED06909412170780 EUDAMED06909412235199 EUDAMED06909412142879 EUDAMED06909412356146 EUDAMED06909412344457 EUDAMED06909412333895 EUDAMED06909412339637 EUDAMED06909412333833 EUDAMED06909412176416 EUDAMED06909412233522 EUDAMED06909412339576 EUDAMED06909412328242 EUDAMED06909412238299 EUDAMED06909412123441 EUDAMED06909412232891 EUDAMED06909412230385 EUDAMED06909412328570 EUDAMED06970402675004 FDA UDI
- Basic UDI-DI
- 6909412YHG2A01XN EUDAMED
- 510(k) Number
- K141724 FDA UDI
- FDA Product Code
- EIH FDA UDI
- EMDN Code
- Q01010199 DENTAL RESTORATION DEVICES - OTHER EUDAMED
- GMDN Term
- Dental appliance fabrication material, ceramic 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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dental appliance fabrication material, ceramic
Zirking by Shandong Huge Dental Material Corporation — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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 | 6909412YHG2A01XN | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Shandong Huge Dental Material Corporation
- EUDAMED SRN
- CN-MF-000013266
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (29)
- EUDAMED 2442d89d-9b87-4a19-aae1-855244e123e0 61 fields · synced Oct 6, 2026
- EUDAMED 9b51d474-df2d-42f1-a540-d6208db56ff8 61 fields · synced May 18, 2026
- FDA UDI a15b87de-8ac8-4c92-a134-d8b6fc688766 33 fields · synced May 25, 2026
- EUDAMED 2442d89d-9b87-4a19-aae1-855244e123e0-1 61 fields · synced Jun 10, 2026
- EUDAMED 9b51d474-df2d-42f1-a540-d6208db56ff8-1 61 fields · synced Jun 10, 2026
- EUDAMED 269d1f0d-5559-4f37-836e-63be74aaafc3 61 fields · synced Jul 14, 2026
- EUDAMED 5e4f260c-8b0f-49f0-8fd6-aeb2c4c91d66 61 fields · synced Jul 16, 2026
- EUDAMED 9c46ec8d-d275-4960-81a7-3a72a8208e52 61 fields · synced Jul 18, 2026
- EUDAMED 68d7f23c-7d7d-475b-9122-3c899caa31a6 61 fields · synced Jul 22, 2026
- EUDAMED b8a20332-c3fa-47a2-858a-3cc02ce7867e 61 fields · synced Jul 26, 2026
- EUDAMED d41686cc-2653-4a31-9b40-73a5d73a4c9e 61 fields · synced Aug 1, 2026
- EUDAMED c1d65a2a-3d33-48ad-a359-27cd8287e617 61 fields · synced Aug 1, 2026
- EUDAMED fc892709-8719-4f8e-843c-04da835135a9 61 fields · synced Aug 1, 2026
- EUDAMED e7d999ea-233b-46be-975a-15875d6fe97d 61 fields · synced Aug 1, 2026
- EUDAMED 50e3671a-575d-49e5-96a9-277551ebfdfd 61 fields · synced Aug 1, 2026
- EUDAMED f9a0994e-a96f-4048-a592-aacce0f573fe 61 fields · synced Aug 1, 2026
- EUDAMED 3d69e04a-b26e-4491-83ab-7cd7c1bc7b98 61 fields · synced Aug 1, 2026
- EUDAMED 21041ae0-f6b6-4611-bb43-40364fd061cd 61 fields · synced Aug 1, 2026
- EUDAMED e0e23ea9-b2ce-480a-8984-aecb3f545619 61 fields · synced Aug 1, 2026
- EUDAMED 28f68f7d-505d-4a7b-b8dd-3ddf9d8134b4 61 fields · synced Aug 1, 2026
- EUDAMED 5bc56408-5342-4f27-8e05-10d27ffac3b1 61 fields · synced Aug 1, 2026
- EUDAMED 808d064c-8f30-4144-8fcc-0a4c91c63421 61 fields · synced Aug 1, 2026
- EUDAMED 6fdf6990-f063-436a-a9bb-14e9a49c0469 61 fields · synced Aug 1, 2026
- EUDAMED 4d08a496-3cd2-4bbc-801c-1fecec71e329 61 fields · synced Aug 1, 2026
- EUDAMED 6d675adc-30ed-4fa7-a3f9-90d068d8c7e4 61 fields · synced Aug 1, 2026
- EUDAMED c018b3aa-52c2-4166-b670-d4c0a6fd30be 61 fields · synced Aug 2, 2026
- EUDAMED 80f71e73-b855-4e16-826d-f1893b5055d6 61 fields · synced Sep 17, 2026
- EUDAMED 64e2a8e9-e365-447b-9a3c-0f371467e242 61 fields · synced Sep 30, 2026
- EUDAMED 3318053f-bdf8-4d62-b518-e20cf700114b 61 fields · synced Sep 30, 2026