Novodent SA
CH-MF-000023309 · Switzerland · Yverdon-les-Bains
Novodent SA is registered in the European database on medical devices as a manufacturer, with 1 537 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIb | 1 090 |
|---|---|
| Class IIa | 447 |
Most frequent device types declared: i-LiNQ Mono Fixture.
Among these devices, 346 are declared sterile, 598 implantable, 163 reusable.
Authorised representative in the Union: Emergo Europe B.V..
Devices declared under this manufacturer
- Bone Level Ti-Base Abutment
- I-Cement Abutment Sealing Plug
- I-Cement Angled Abutment
- Mono Implant Mini Rough
- Mono Implant Smooth -Micro
- Multi Unit Abutment Plastic Cylinder- Crown
- Tapered Aggressive Drill
- Tissue Level Short Fixture Straight
- Twist Drill
- Zygoma Healing Abutment
- Zygoma Implant
- i-system Multi Unit Abutment Analog
Showing 12 of 1 537 declared devices.
Catalogue references include I-SILCE50L-25, I-SMUALA, I-SSAA6565, MOT3529, MSM3523- LAb, S-BTiA05.
European nomenclature codes declared: P01020180, P01020101, Q010399.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 1 537 |
| Country of registration | Switzerland |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 1 537 |
|---|---|
| Found in the U.S. device database | 377 |
| Share | 24.5 % |
Canadian market access
| Health Canada licence listing | Not found in the Canadian register |
|---|
⚠️ Canada lists no Class I devices at all — what that excludes.
North American profile: Neither register. Novodent SA was not found in either the U.S. or the Canadian register.