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i-system Ball Abutment
EUDAMEDClass IIb (EU MDR)
Ref I-SBA60(3)Ref I-SBA10(2)Ref I-SBA10(3)Ref I-SBA50(3)Ref I-SBA30(3)Ref I-SBA40(3)Ref I-SBA30(2)Ref I-SBA20(3)Ref I-SBA60(2.5)Ref I-SBA20(2.5)Ref I-SBA30(2.5)Ref I-SBA40(2)Ref I-SBA40(2.5)
by Novodent SA
Identity
- Trade Name
- i-system Ball Abutment EUDAMED
- Device Name
- i-system Ball Abutment EUDAMED
- Model / Reference
- I-SBA60(3) EUDAMEDI-SBA10(2) EUDAMEDI-SBA10(3) EUDAMEDI-SBA50(3) EUDAMEDI-SBA30(3) EUDAMEDI-SBA40(3) EUDAMEDI-SBA30(2) EUDAMEDI-SBA20(3) EUDAMEDI-SBA60(2.5) EUDAMEDI-SBA20(2.5) EUDAMEDI-SBA30(2.5) EUDAMEDI-SBA40(2) EUDAMEDI-SBA40(2.5) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07640168186890 EUDAMED07640168186722 EUDAMED07640168186845 EUDAMED07640168186883 EUDAMED07640168186869 EUDAMED07640168186876 EUDAMED07640168186746 EUDAMED07640168186852 EUDAMED07640168186838 EUDAMED07640168186791 EUDAMED07640168186807 EUDAMED07640168186753 EUDAMED07640168186814 EUDAMED
- Basic UDI-DI
- B-07640168186890 EUDAMEDB-07640168186722 EUDAMEDB-07640168186845 EUDAMEDB-07640168186883 EUDAMEDB-07640168186869 EUDAMEDB-07640168186876 EUDAMEDB-07640168186746 EUDAMEDB-07640168186852 EUDAMEDB-07640168186838 EUDAMEDB-07640168186791 EUDAMEDB-07640168186807 EUDAMEDB-07640168186753 EUDAMEDB-07640168186814 EUDAMED
- EMDN Code
- P01020180 DENTAL IMPLANTS - ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
i-system Ball Abutment by Novodent SA — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-07640168186890 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Novodent SA
- EUDAMED SRN
- CH-MF-000023309
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (13)
- EUDAMED 3c65a24d-bf5a-47a1-b385-3882a4e7a245 61 fields · synced Sep 17, 2026
- EUDAMED 44028477-fe8f-41d0-a39d-10dfd110b677 61 fields · synced May 16, 2026
- EUDAMED 3faf7ef2-6cfa-4417-b82f-2005e840b194 61 fields · synced May 16, 2026
- EUDAMED 2c9c93a2-38ea-4e6e-a994-05767ed57a1c 61 fields · synced May 17, 2026
- EUDAMED be34052c-3010-47e3-84a4-045fc99d9e7f 61 fields · synced May 17, 2026
- EUDAMED 08f3205e-76cb-4747-8abb-78e16f87c116 61 fields · synced May 17, 2026
- EUDAMED 86e970a4-865e-43ea-a1c6-c1686a7b0545 61 fields · synced May 18, 2026
- EUDAMED 38fc1bda-1ec3-4c32-8ab1-95d6061fbf7c 61 fields · synced May 18, 2026
- EUDAMED 777b2f15-2c25-40a1-924c-c40e32b27861 61 fields · synced May 18, 2026
- EUDAMED a1df2477-1b33-4ac7-b166-89bcf5b3c38d 61 fields · synced May 18, 2026
- EUDAMED 53efa9a1-b6c9-493e-b72a-bf1ca1af5a38 61 fields · synced May 18, 2026
- EUDAMED fbf1fdd6-a74d-4b53-8b15-021e924973ae 61 fields · synced May 18, 2026
- EUDAMED 210749e2-5cbe-4522-b015-ad7fb3ea1923 61 fields · synced May 19, 2026