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i-system Shouldered Abutment
EUDAMEDClass IIb (EU MDR)
Ref I-SSA6050(2)Ref I-SSA3040(2)Ref I-SSA3050(2)Ref I-SSA6040(2)Ref I-SSA4065(3)Ref I-SSA6065(3)Ref I-SSA4050(2.5)Ref I-SSA5050(3)Ref I-SSA1050(2)Ref I-SSA3050(2.5)Ref I-SSA3065(3)Ref I-SSA2040(2)Ref I-SSA1040(2.5)Ref I-SSA1050(2.5)Ref I-SSA5040(2.5)Ref I-SSA2050(3)Ref I-SSA3050(3)Ref I-SSA6050(2.5)Ref I-SSA4050(2)Ref I-SSA2050(2)Ref I-SSA5050(2)Ref I-SSA6050(3)Ref I-SSA2050(2.5)
by Novodent SA
Identity
- Trade Name
- i-system Shouldered Abutment EUDAMED
- Device Name
- i-system Shouldered Abutment EUDAMED
- Model / Reference
- I-SSA6050(2) EUDAMEDI-SSA3040(2) EUDAMEDI-SSA3050(2) EUDAMEDI-SSA6040(2) EUDAMEDI-SSA4065(3) EUDAMEDI-SSA6065(3) EUDAMEDI-SSA4050(2.5) EUDAMEDI-SSA5050(3) EUDAMEDI-SSA1050(2) EUDAMEDI-SSA3050(2.5) EUDAMEDI-SSA3065(3) EUDAMEDI-SSA2040(2) EUDAMEDI-SSA1040(2.5) EUDAMEDI-SSA1050(2.5) EUDAMEDI-SSA5040(2.5) EUDAMEDI-SSA2050(3) EUDAMEDI-SSA3050(3) EUDAMEDI-SSA6050(2.5) EUDAMEDI-SSA4050(2) EUDAMEDI-SSA2050(2) EUDAMEDI-SSA5050(2) EUDAMEDI-SSA6050(3) EUDAMEDI-SSA2050(2.5) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07640168185015 EUDAMED07640168184940 EUDAMED07640168184957 EUDAMED07640168185008 EUDAMED07640168185213 EUDAMED07640168185251 EUDAMED07640168185091 EUDAMED07640168185220 EUDAMED07640168184919 EUDAMED07640168185077 EUDAMED07640168185190 EUDAMED07640168184926 EUDAMED07640168185022 EUDAMED07640168185039 EUDAMED07640168185107 EUDAMED07640168185169 EUDAMED07640168185183 EUDAMED07640168185138 EUDAMED07640168184971 EUDAMED07640168184933 EUDAMED07640168184995 EUDAMED07640168185244 EUDAMED07640168185053 EUDAMED
- Basic UDI-DI
- B-07640168185015 EUDAMEDB-07640168184940 EUDAMEDB-07640168184957 EUDAMEDB-07640168185008 EUDAMEDB-07640168185213 EUDAMEDB-07640168185251 EUDAMEDB-07640168185091 EUDAMEDB-07640168185220 EUDAMEDB-07640168184919 EUDAMEDB-07640168185077 EUDAMEDB-07640168185190 EUDAMEDB-07640168184926 EUDAMEDB-07640168185022 EUDAMEDB-07640168185039 EUDAMEDB-07640168185107 EUDAMEDB-07640168185169 EUDAMEDB-07640168185183 EUDAMEDB-07640168185138 EUDAMEDB-07640168184971 EUDAMEDB-07640168184933 EUDAMEDB-07640168184995 EUDAMEDB-07640168185244 EUDAMEDB-07640168185053 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 Shouldered 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-07640168185015 | 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 (23)
- EUDAMED 54840497-d061-43c0-a1a7-bf72a217fecf 61 fields · synced Jul 27, 2026
- EUDAMED 99138718-8bcd-4c03-984e-3deae4659de2 61 fields · synced May 16, 2026
- EUDAMED 95ea690c-f977-4d47-bd8e-bdd1612aa6aa 61 fields · synced May 17, 2026
- EUDAMED fbe7fec2-6903-4091-bb0d-4d14a471edff 61 fields · synced May 17, 2026
- EUDAMED 4f793859-8742-4fe8-aef3-6e325404a532 61 fields · synced May 17, 2026
- EUDAMED 4f4bae65-36fa-4e5b-8dad-0f780532b060 61 fields · synced May 17, 2026
- EUDAMED b674ac17-f264-4b41-9a4c-4d96f9d4c82f 61 fields · synced May 17, 2026
- EUDAMED d5f1deca-aae7-442c-b7c8-67e2d899eec5 61 fields · synced May 17, 2026
- EUDAMED 31262416-0b4e-4f87-abc9-d59f0699b806 61 fields · synced May 18, 2026
- EUDAMED 5e887cf0-253d-4714-a8b4-69960897e132 61 fields · synced May 18, 2026
- EUDAMED 84a5b61e-4d75-4ee0-929d-8df3d9142dbf 61 fields · synced May 18, 2026
- EUDAMED a8228f08-75bf-4c0f-872f-e4e8d4961fe6 61 fields · synced May 18, 2026
- EUDAMED bcfcfd94-bd73-442b-bb55-b595eb6f09ae 61 fields · synced May 18, 2026
- EUDAMED 82e50390-aca6-4eb3-b8ef-b3a6d43be717 61 fields · synced May 18, 2026
- EUDAMED 8685d049-dc24-4693-8a52-929aac63ecb1 61 fields · synced May 18, 2026
- EUDAMED 5053d016-e4c9-4467-8c35-f604f9890e43 61 fields · synced May 18, 2026
- EUDAMED 1806449c-e5ae-4d3c-892b-550a4878bf71 61 fields · synced May 18, 2026
- EUDAMED 247a4f66-b45d-4a6b-8e01-2adb95bbec21 61 fields · synced May 18, 2026
- EUDAMED fb69c7ca-c7f8-49cb-b4ff-8cfa4fd62138 61 fields · synced May 18, 2026
- EUDAMED 68f37e7b-f9ad-4619-893f-9cba4dffa12d 61 fields · synced May 18, 2026
- EUDAMED 45269875-3784-4653-ba96-83f62b599705 61 fields · synced May 19, 2026
- EUDAMED e12b377c-b6db-48fb-8c9e-464303d4a809 61 fields · synced May 19, 2026
- EUDAMED 2fcc39b5-1878-4d4a-a6f5-6774ecbb9515 61 fields · synced May 19, 2026