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ZİRCON.X, Zircon PreShade Bloc (98x12) ST / APW9812STCA3, 5
EUDAMEDClass IIa (EU MDR)
Ref PRD.01.300.ZPS12-A3,5Ref PRD.01.300.ZPS22-A3Ref PRD.01.300.ZPS22-A3,5Ref PRD.01.300.ZPS12-A3
Identity
- Trade Name
- ZİRCON.X, Zircon PreShade Bloc (98x12) ST / APW9812STCA3,5 EUDAMEDZİRCON.X, Zircon PreShade Bloc (98x22) ST / APW9822STCA3 EUDAMEDZİRCON.X, Zircon PreShade Bloc (98x22) ST / APW9822SHTCA3,5 EUDAMEDZİRCON.X, Zircon PreShade Bloc (98x12) ST / APW9812STCA3 EUDAMED
- Device Name
- ZIRCON.X EUDAMED
- Model / Reference
- PRD.01.300.ZPS12-A3,5 EUDAMEDPRD.01.300.ZPS22-A3 EUDAMEDPRD.01.300.ZPS22-A3,5 EUDAMEDPRD.01.300.ZPS12-A3 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 42602962702082 EUDAMED04260296272116 EUDAMED04260296273687 EUDAMED04260296273694 EUDAMED04260296272079 EUDAMED
- Basic UDI-DI
- 426029627ZIR001BL EUDAMED
- EMDN Code
- Q01010199 DENTAL RESTORATION DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Category: Dental appliance fabrication material, ceramic
ZİRCON.X, Zircon PreShade Bloc (98x12) ST / APW9812STCA3, 5 by President Dental GmbH — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 426029627ZIR001BL | Class IIa | Active |
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Manufacturer
- Manufacturer
- President Dental GmbH
- EUDAMED SRN
- DE-MF-000014901
Sources (7)
- EUDAMED 7cefa48f-96dc-43e7-a415-1b22cf568c44 61 fields · synced Oct 6, 2026
- EUDAMED 7cefa48f-96dc-43e7-a415-1b22cf568c44-1 61 fields · synced Jun 10, 2026
- EUDAMED 5dcf3b19-be59-4183-b068-80ac2763ab42-1 61 fields · synced Jul 11, 2026
- EUDAMED eaed526e-ae9c-44b1-ae44-2cc8d72552aa 61 fields · synced Jul 15, 2026
- EUDAMED 82018fb3-5e5c-423b-9fc2-8e7eaec265ec-1 61 fields · synced Jul 17, 2026
- EUDAMED 82018fb3-5e5c-423b-9fc2-8e7eaec265ec-2 61 fields · synced Jul 17, 2026
- EUDAMED da113bc1-8fba-4922-84a3-688f354a78f1 61 fields · synced Jul 29, 2026