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IOS Implant Replica Nobel Biocare N1™ TCC RP
EUDAMEDFDA UDIClass I (EU MDR)
Ref 300965
Identity
- Trade Name
- IOS Implant Replica Nobel Biocare N1™ TCC RP EUDAMEDNobel Biocare N1™ FDA UDI
- Generic Name
- Dental implant suprastructure, temporary, preformed, single-use FDA UDI
- Device Name
- Lab tools for prosthetics EUDAMEDIOS Implant Replica Nobel Biocare N1™ TCC RP FDA UDI
- Model / Reference
- 300965 EUDAMEDFDA UDI
- Description
- IOS Implant Replica Nobel Biocare N1™ TCC RP FDA UDI
Identifiers
- Catalog Number
- 300965 FDA UDI
- Primary DI / UDI-DI
- 07332747177008 EUDAMEDFDA UDI
- Basic UDI-DI
- 73327470000002036S EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- Q010207 DENTAL IMPRESSION DEVICES FOR PROSTHETIC DENTISTRY EUDAMED
- GMDN Term
- Dental implant suprastructure, temporary, preformed, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.3980 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
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
IOS Implant Replica Nobel Biocare N1™ TCC RP by Nobel Biocare AB — Class I — 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 | 73327470000002036S | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Nobel Biocare AB
- EUDAMED SRN
- SE-MF-000000009
Sources (2)
- EUDAMED 0cd520ee-b63b-42f7-a63e-0fb6bb0ede15 61 fields · synced Jul 20, 2026
- FDA UDI c2b0fb9f-58c9-4469-8677-80708106f2f2 36 fields · synced May 30, 2026