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Atrophic Maxillary Zygoma Implant
EUDAMEDClass IIb (EU MDR)
Ref S-ZAM47.5Ref S-ZAM45Ref S-ZAM55Ref S-ZAM50Ref S-ZAM57.5Ref S-ZAM42.5Ref S-ZAM52.5
by Novodent SA
Identity
- Trade Name
- Atrophic Maxillary Zygoma Implant EUDAMED
- Device Name
- Atrophic Maxillary Zygoma Implant EUDAMED
- Model / Reference
- S-ZAM47.5 EUDAMEDS-ZAM45 EUDAMEDS-ZAM55 EUDAMEDS-ZAM50 EUDAMEDS-ZAM57.5 EUDAMEDS-ZAM42.5 EUDAMEDS-ZAM52.5 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07640168188948 EUDAMED07640168188931 EUDAMED07640168188979 EUDAMED07640168188955 EUDAMED07640168188986 EUDAMED07640168188924 EUDAMED07640168188962 EUDAMED
- Basic UDI-DI
- B-07640168188948 EUDAMEDB-07640168188931 EUDAMEDB-07640168188979 EUDAMEDB-07640168188955 EUDAMEDB-07640168188986 EUDAMEDB-07640168188924 EUDAMEDB-07640168188962 EUDAMED
- EMDN Code
- P01020101 DENTAL IMPLANTS EUDAMEDP01020180 DENTAL IMPLANTS - ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
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
Atrophic Maxillary Zygoma Implant 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-07640168188948 | 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 (7)
- EUDAMED 186163f0-5e80-4035-9437-d84fa11a7809 61 fields · synced Aug 3, 2026
- EUDAMED 766f9423-f73c-4a94-a093-a72edb4da31a 61 fields · synced May 17, 2026
- EUDAMED cf3105b7-33da-4feb-9a64-c8daff9f7360 61 fields · synced May 18, 2026
- EUDAMED 4984a74e-46d4-4fff-8fef-f4712159f2ef 61 fields · synced May 18, 2026
- EUDAMED a1aa54bf-af71-4c68-a56f-91a256a0c551 61 fields · synced May 18, 2026
- EUDAMED 3b4d6740-fec3-4844-8ef8-9c9afca6d12c 61 fields · synced May 18, 2026
- EUDAMED 87276c8b-bc26-4c52-babe-27937a1f3453 61 fields · synced May 19, 2026