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NPr FCZ Imp Crown ASC CC WP w-u 1-25° s0
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref 77319
Identity
- Trade Name
- NPr FCZ Imp Crown ASC CC WP w-u 1-25° s0 EUDAMEDNobelProcera® FDA UDI
- Generic Name
- Dental implant suprastructure, permanent, preformed FDA UDI
- Device Name
- Dental Prostheses Zr - Single-unit EUDAMEDNPr FCZ Imp Crown ASC CC WP w-u 1-25° s0 FDA UDI
- Model / Reference
- 77319 EUDAMEDFDA UDI
- Description
- NPr FCZ Imp Crown ASC CC WP w-u 1-25° s0 FDA UDI
Identifiers
- Catalog Number
- 77319 FDA UDI
- Primary DI / UDI-DI
- 07332747090017 EUDAMEDFDA UDI
- Basic UDI-DI
- 73327470000002106P EUDAMED
- FDA Product Code
- NHA FDA UDI
- EMDN Code
- P01020101 DENTAL IMPLANTS EUDAMED
- GMDN Term
- Dental implant suprastructure, permanent, preformed FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3630 FDA UDI
- Market of Registration
- Sweden EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Sutures
Yes
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
NPr FCZ Imp Crown ASC CC WP w-u 1-25° s0 by Nobel Biocare AB — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 73327470000002106P | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Nobel Biocare AB
- EUDAMED SRN
- SE-MF-000000009
Sources (2)
- EUDAMED 68f2d298-ad03-467a-b350-e5292724a5d5 61 fields · synced Aug 1, 2026
- FDA UDI 485befa7-ed87-4698-8d3a-7f1a921b20f9 36 fields · synced May 30, 2026