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Dental implants
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref 110-4114602Ref 110-3308602Ref 110-3810602Ref 110-3914-02Ref 110-4108602Ref 110-3910-02Ref 110-4514602Ref 110-3814602Ref 110-2914602Ref 126-4125-35Ref 110-4512602Ref 110-5065602Ref 131-3003-50Ref 121-2208-00Ref 131-3005-40Ref 131-3007-50Ref 121-3008-00Ref 131-2207-50Ref 121-2205-05Ref 131-2205-40
by Leone S.p.a.
Identity
- Trade Name
- LEONE SPA FDA UDI
- Generic Name
- Dental implant suprastructure, permanent, preformed FDA UDI
- Device Name
- Dental implants EUDAMEDMUA PLUS 3.0 ANG.35° GH5 FDA UDI
- Model / Reference
- 110-4114602 EUDAMED110-3308602 EUDAMED110-3810602 EUDAMED110-3914-02 EUDAMED110-4108602 EUDAMED110-3910-02 EUDAMED110-4514602 EUDAMED110-3814602 EUDAMED110-2914602 EUDAMED126-4125-35 EUDAMEDFDA UDI110-4512602 EUDAMED110-5065602 EUDAMED131-3003-50 EUDAMED121-2208-00 EUDAMED131-3005-40 EUDAMED131-3007-50 EUDAMED121-3008-00 EUDAMED131-2207-50 EUDAMED121-2205-05 EUDAMED131-2205-40 EUDAMED
- Description
- MUA PLUS 3.0 ANG.35° GH5 FDA UDI
Identifiers
- Catalog Number
- 126-4125-35 FDA UDI
- Primary DI / UDI-DI
- 08033707097129 EUDAMED08033707097051 EUDAMED08033707097150 EUDAMED08033707103400 EUDAMED08033707097099 EUDAMED08033707103387 EUDAMED08033707097211 EUDAMED08033707097174 EUDAMED08033707097044 EUDAMED08033707098966 EUDAMEDFDA UDI08033707097204 EUDAMED08033707097136 EUDAMED08033707106289 EUDAMED08033707106173 EUDAMED08033707106234 EUDAMED08033707106302 EUDAMED08033707106180 EUDAMED08033707106272 EUDAMED08033707106142 EUDAMED08033707106203 EUDAMED
- Basic UDI-DI
- B-08033707097129 EUDAMEDB-08033707097051 EUDAMEDB-08033707097150 EUDAMEDB-08033707103400 EUDAMEDB-08033707097099 EUDAMEDB-08033707103387 EUDAMEDB-08033707097211 EUDAMEDB-08033707097174 EUDAMEDB-08033707097044 EUDAMEDB-08033707098966 EUDAMEDB-08033707097204 EUDAMEDB-08033707097136 EUDAMEDB-08033707106289 EUDAMEDB-08033707106173 EUDAMEDB-08033707106234 EUDAMEDB-08033707106302 EUDAMEDB-08033707106180 EUDAMEDB-08033707106272 EUDAMEDB-08033707106142 EUDAMEDB-08033707106203 EUDAMED
- 510(k) Number
- K050586 FDA UDI
- FDA Product Code
- DZE FDA UDI
- EMDN Code
- P01020101 DENTAL IMPLANTS EUDAMEDP01020180 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
Yes
EUDAMEDFDA UDIEUDAMED
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
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-08033707097129 | 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 (21)
- EUDAMED a7e5f90b-befc-49df-b6dc-b283437aaec5 61 fields · synced Jul 31, 2026
- EUDAMED 0b45f3c7-4713-489e-8e1d-2829d82cbe60 61 fields · synced May 17, 2026
- EUDAMED ecf07cb9-0fee-4f90-992c-fc760f4f32fa 61 fields · synced May 17, 2026
- EUDAMED b0e0967f-cc02-4ace-ab4e-394e44cad00b 61 fields · synced May 17, 2026
- EUDAMED 7d5627e8-a684-4cf9-91e1-7a2e06389e28 61 fields · synced May 17, 2026
- EUDAMED 475e2231-eef1-47ee-949b-4ecef52a823e 61 fields · synced May 17, 2026
- EUDAMED 92d0ae00-8f2c-47ed-ac24-357cddc0f852 61 fields · synced May 17, 2026
- EUDAMED ee88e394-4903-4790-a94c-8850cd9c02ec 61 fields · synced May 18, 2026
- EUDAMED 092b0fc9-6381-400d-be04-2f200584d47e 61 fields · synced May 18, 2026
- EUDAMED 4932be3b-8dc9-48b2-a2f7-62e5f769db40 61 fields · synced May 18, 2026
- EUDAMED 96da5dca-ef59-4e91-b074-9c0658168860 61 fields · synced May 18, 2026
- EUDAMED 8343acf5-20b7-4907-abac-a0c185e98b43 61 fields · synced May 18, 2026
- FDA UDI ecfa6ac8-adb1-4819-a787-021e2d209a38 35 fields · synced May 30, 2026
- EUDAMED 622ace1e-48a0-4a45-b386-6d855f3c219f 61 fields · synced Jun 19, 2026
- EUDAMED c1be5401-095b-46de-851d-9d835c17723b 61 fields · synced Jul 9, 2026
- EUDAMED 2fbd1e80-4f1f-4c63-a0eb-4be34f94c0cf 61 fields · synced Jul 14, 2026
- EUDAMED 88e41dc9-e583-420e-bac3-117af6e5d968 61 fields · synced Jul 17, 2026
- EUDAMED d77c01b6-fb4f-4ccc-9b8c-573f86f4ed46 61 fields · synced Jul 20, 2026
- EUDAMED 42edb0b6-ceea-4c6d-824f-ae9da304a849 61 fields · synced Jul 22, 2026
- EUDAMED b45077dd-ed45-43f4-bdba-51c5f38c589b 61 fields · synced Jul 25, 2026
- EUDAMED 9880507a-45f9-4809-88fe-7eed8bbb1e18 61 fields · synced Jul 31, 2026