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Abutments for Dental Implants
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref 123-3315-01
by Leone S.p.a.
Identity
- Trade Name
- LEONE SPA FDA UDI
- Generic Name
- Dental implant suprastructure, permanent, preformed FDA UDI
- Device Name
- Abutments for Dental Implants EUDAMEDBALL HEAD ABUTMENT 15°IMP 3,3 GH 1,5MM FDA UDI
- Model / Reference
- 123-3315-01 EUDAMEDFDA UDI
- Description
- BALL HEAD ABUTMENT 15°IMP 3,3 GH 1,5MM FDA UDI
Identifiers
- Catalog Number
- 123-3315-01 FDA UDI
- Primary DI / UDI-DI
- 08033707087373 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08033707087373 EUDAMED
- 510(k) Number
- K050586 FDA UDI
- FDA Product Code
- DZE FDA UDI
- EMDN Code
- P01020180 DENTAL IMPLANTS - ACCESSORIES EUDAMED
- GMDN Term
- Dental implant suprastructure, permanent, preformed FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3640 FDA UDI
- Market of Registration
- Italy 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
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
High-level Disinfectant FDA UDI
Abutments for Dental Implants by Leone S.p.a. — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08033707087373 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Leone S.p.a.
- EUDAMED SRN
- IT-MF-000005986
Sources (2)
- EUDAMED 645d0880-1731-4540-b273-bc491f666570 61 fields · synced Jun 18, 2026
- FDA UDI 23472a18-ebc9-4ed1-879a-282e29470598 35 fields · synced May 30, 2026