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Abutments for Dental Implants
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref 127-2205-07Ref 124-4103D01Ref 120-3310D45Ref 123-3003-01Ref 124-4103D02Ref 127-3005-35Ref 123-2201-01Ref 123-2203-15Ref 127-2203-15Ref 127-3001-07Ref 127-3003-15Ref 123-2205-15Ref 123-3005-25Ref 123-3005-15Ref 161-3310-00Ref 127-2201-15Ref 123-3001-01Ref 124-4103D03Ref 161-5510-00Ref 127-2203-25Ref 161-4110-00Ref 123-3001-07Ref 120-4110D41Ref 127-3003-07Ref 127-3005-07Ref 161-4938-22Ref 161-5510-15Ref 127-2205-25Ref 123-2203-07Ref 161-4810-15Ref 123-3001-25Ref 123-2205-25Ref 127-3003-35Ref 127-0410-00Ref 127-2205-01Ref 129-4103-01Ref 161-4510-00Ref 161-4810-00Ref 123-2205-01Ref 123-3003-35Ref 127-2203-01Ref 123-3005-07Ref 127-0101-00Ref 123-3005-01Ref 131-2207-40
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 EUDAMEDDental implants EUDAMEDABUTMENT ANATOMICAL ANG.15° IMP.4,1 GH3 FDA UDI
- Model / Reference
- 127-2205-07 EUDAMED124-4103D01 EUDAMED120-3310D45 EUDAMED123-3003-01 EUDAMED124-4103D02 EUDAMED127-3005-35 EUDAMED123-2201-01 EUDAMED123-2203-15 EUDAMED127-2203-15 EUDAMED127-3001-07 EUDAMED127-3003-15 EUDAMED123-2205-15 EUDAMED123-3005-25 EUDAMED123-3005-15 EUDAMED161-3310-00 EUDAMED127-2201-15 EUDAMED123-3001-01 EUDAMED124-4103D03 EUDAMED161-5510-00 EUDAMED127-2203-25 EUDAMED161-4110-00 EUDAMED123-3001-07 EUDAMED120-4110D41 EUDAMED127-3003-07 EUDAMED127-3005-07 EUDAMED161-4938-22 EUDAMED161-5510-15 EUDAMED127-2205-25 EUDAMED123-2203-07 EUDAMED161-4810-15 EUDAMED123-3001-25 EUDAMED123-2205-25 EUDAMED127-3003-35 EUDAMED127-0410-00 EUDAMED127-2205-01 EUDAMED129-4103-01 EUDAMEDFDA UDI161-4510-00 EUDAMED161-4810-00 EUDAMED123-2205-01 EUDAMED123-3003-35 EUDAMED127-2203-01 EUDAMED123-3005-07 EUDAMED127-0101-00 EUDAMED123-3005-01 EUDAMED131-2207-40 EUDAMED
- Description
- ABUTMENT ANATOMICAL ANG.15° IMP.4,1 GH3 FDA UDI
Identifiers
- Catalog Number
- 129-4103-01 FDA UDI
- Primary DI / UDI-DI
- 08033707103530 EUDAMED08033707094364 EUDAMED08033707094418 EUDAMED08033707103943 EUDAMED08033707094333 EUDAMED08033707103707 EUDAMED08033707103769 EUDAMED08033707103820 EUDAMED08033707103493 EUDAMED08033707103585 EUDAMED08033707103639 EUDAMED08033707103875 EUDAMED08033707104025 EUDAMED08033707104018 EUDAMED08033707082156 EUDAMED08033707103455 EUDAMED08033707103905 EUDAMED08033707094487 EUDAMED08033707099697 EUDAMED08033707103509 EUDAMED08033707082170 EUDAMED08033707103912 EUDAMED08033707094302 EUDAMED08033707103622 EUDAMED08033707103677 EUDAMED08033707099659 EUDAMED08033707099703 EUDAMED08033707103554 EUDAMED08033707103813 EUDAMED08033707082200 EUDAMED08033707103936 EUDAMED08033707103882 EUDAMED08033707103653 EUDAMED08033707103738 EUDAMED08033707103523 EUDAMED08033707076612 EUDAMEDFDA UDI08033707099635 EUDAMED08033707082194 EUDAMED08033707103851 EUDAMED08033707103981 EUDAMED08033707103479 EUDAMED08033707104001 EUDAMED08033707103745 EUDAMED08033707103998 EUDAMED08033707106210 EUDAMED
- Basic UDI-DI
- B-08033707103530 EUDAMEDB-08033707094364 EUDAMEDB-08033707094418 EUDAMEDB-08033707103943 EUDAMEDB-08033707094333 EUDAMEDB-08033707103707 EUDAMEDB-08033707103769 EUDAMEDB-08033707103820 EUDAMEDB-08033707103493 EUDAMEDB-08033707103585 EUDAMEDB-08033707103639 EUDAMEDB-08033707103875 EUDAMEDB-08033707104025 EUDAMEDB-08033707104018 EUDAMEDB-08033707082156 EUDAMEDB-08033707103455 EUDAMEDB-08033707103905 EUDAMEDB-08033707094487 EUDAMEDB-08033707099697 EUDAMEDB-08033707103509 EUDAMEDB-08033707082170 EUDAMEDB-08033707103912 EUDAMEDB-08033707094302 EUDAMEDB-08033707103622 EUDAMEDB-08033707103677 EUDAMEDB-08033707099659 EUDAMEDB-08033707099703 EUDAMEDB-08033707103554 EUDAMEDB-08033707103813 EUDAMEDB-08033707082200 EUDAMEDB-08033707103936 EUDAMEDB-08033707103882 EUDAMEDB-08033707103653 EUDAMEDB-08033707103738 EUDAMEDB-08033707103523 EUDAMEDB-08033707076612 EUDAMEDB-08033707099635 EUDAMEDB-08033707082194 EUDAMEDB-08033707103851 EUDAMEDB-08033707103981 EUDAMEDB-08033707103479 EUDAMEDB-08033707104001 EUDAMEDB-08033707103745 EUDAMEDB-08033707103998 EUDAMEDB-08033707106210 EUDAMED
- 510(k) Number
- K050586 FDA UDI
- FDA Product Code
- DZE FDA UDI
- EMDN Code
- P01020180 DENTAL IMPLANTS - ACCESSORIES EUDAMEDP01020101 DENTAL IMPLANTS 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 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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization 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-08033707103530 | 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 (46)
- EUDAMED 2cddc717-9495-4379-b29b-64ae93014737 61 fields · synced Oct 1, 2026
- EUDAMED 5d86e677-db6f-429b-8d03-d2ab6573ed2b 61 fields · synced May 11, 2026
- EUDAMED 84e43fe0-6583-4c28-8694-55ff5af38b6b 61 fields · synced May 11, 2026
- EUDAMED 0f74360b-6e75-4eac-9906-ad972bc542d8 61 fields · synced May 11, 2026
- EUDAMED 18e129f4-334a-48d1-8785-d485ff3496c3 61 fields · synced May 11, 2026
- EUDAMED a1d5bfa2-70ad-48cf-a7cf-f6fe199f6fda 61 fields · synced May 16, 2026
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- EUDAMED 9c2aefcc-db7e-4521-88d4-b64d277f3ce7 61 fields · synced May 16, 2026
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- EUDAMED 44df7097-23ae-4ded-823b-8e13d6f46d88 61 fields · synced May 17, 2026
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- EUDAMED bca6319f-a5fe-4581-bf35-41f370e2dfba 61 fields · synced May 17, 2026
- EUDAMED 86f44264-a5fa-46fe-bd48-7cc228219e9a 61 fields · synced May 17, 2026
- EUDAMED e521633b-493b-4e9c-82aa-c2ae93ba5607 61 fields · synced May 17, 2026
- EUDAMED 362e7586-f310-4ff8-9e92-c03ae8409226 61 fields · synced May 17, 2026
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- EUDAMED 97a026c1-d88d-4b1f-bee0-1de17e088de7 61 fields · synced May 18, 2026
- EUDAMED 9d88e9cc-5b3a-4006-9022-bf8e8e875eab 61 fields · synced May 18, 2026
- EUDAMED e60cdc62-5591-489d-8283-abe42d10af7f 61 fields · synced May 18, 2026
- EUDAMED e806dae7-23ab-4749-914f-552500af01a3 61 fields · synced May 18, 2026
- EUDAMED 4521fe5b-59f3-4416-8035-5f6f5d0df837 61 fields · synced May 18, 2026
- EUDAMED bdca2543-b7cc-464b-8aa7-8f574ce064b5 61 fields · synced May 18, 2026
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- EUDAMED 691aa783-79c9-498f-9276-08eee2e56d00 61 fields · synced May 18, 2026
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- EUDAMED 5dd2f859-818c-4371-b052-6ab3308bfc29 61 fields · synced May 18, 2026
- EUDAMED 6b08e7f6-cdeb-45bb-9c54-2966bfb256b2 61 fields · synced May 18, 2026
- EUDAMED 77cff13d-82e4-445e-93c6-7a0ba35d8858 61 fields · synced May 19, 2026
- EUDAMED d3f29f14-155a-4382-b998-2c225f5476da 61 fields · synced May 19, 2026
- EUDAMED 8025d837-ff54-48b4-9416-ff79790e4e1a 61 fields · synced May 19, 2026
- FDA UDI e095f837-1324-405c-a346-aa3bd7e016f5 35 fields · synced May 29, 2026
- EUDAMED e83c21b1-061b-4309-b140-a7ac3da16184 61 fields · synced Jul 20, 2026