Identity
- Trade Name
- Tuff PRO Int. Hex Ti. Implant EUDAMEDTuff PRO Implant FDA UDI
- Generic Name
- Screw endosteal dental implant, two-piece FDA UDI
- Device Name
- Classic Implants Hex EUDAMEDTuff PRO, D5.0, L13, Int. Hex Ti. Implant FDA UDI
- Model / Reference
- NMAF5013 EUDAMEDFDA UDI
- Description
- Tuff PRO, D5.0, L13, Int. Hex Ti. Implant FDA UDI
Identifiers
- Catalog Number
- NMAF5013 FDA UDI
- Primary DI / UDI-DI
- 07290108817089 EUDAMEDFDA UDI
- Basic UDI-DI
- B-07290108817089 EUDAMED
- FDA Product Code
- DZE FDA UDI
- EMDN Code
- P01020101 DENTAL IMPLANTS EUDAMED
- GMDN Term
- Screw endosteal dental implant, two-piece FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3640 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Conditional FDA UDI
Category: Screw endosteal dental implant, two-piece
Tuff PRO Implant by Noris Medical Ltd — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Noris Medical Ltd
Sources (2)
- FDA UDI 0232082c-176c-4a43-bc5b-dfa88538e90a 35 fields · synced Oct 7, 2026
- EUDAMED 35dba929-584e-4759-b614-3ad2cd69fe82 61 fields · synced Jul 8, 2026