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Procera® Abutm Zr Bmk Syst RP W-u Light
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref 78019
Identity
- Trade Name
- Procera® Abutm Zr Bmk Syst RP W-u Light EUDAMEDNobelProcera® FDA UDI
- Generic Name
- Dental implant suprastructure, permanent, preformed FDA UDI
- Device Name
- NobelProcera prosthetic abutments Zr EUDAMEDProcera® Abutm Zr Bmk Syst RP W-u Light FDA UDI
- Model / Reference
- 78019 EUDAMEDFDA UDI
- Description
- Procera® Abutm Zr Bmk Syst RP W-u Light FDA UDI
Identifiers
- Catalog Number
- 78019 FDA UDI
- Primary DI / UDI-DI
- 07332747095883 EUDAMEDFDA UDI
- Basic UDI-DI
- 73327470000001677F 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
Procera® Abutm Zr Bmk Syst RP W-u Light 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 | 73327470000001677F | 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 b54e3114-6e4e-464b-b69e-4d665a809142 61 fields · synced Jul 15, 2026
- FDA UDI 713111e0-0a74-4b0c-9c63-6b62a5dcccb0 36 fields · synced May 30, 2026