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Sign in to claim this brandNovodent SA
Switzerland·CH-MF-000023309
Last updated September 18, 2026
What Novodent SA makes
Novodent SA manufactures reusable surgical screwdrivers for dental procedures, as well as preformed permanent suprastructures for dental implants. Their portfolio includes dental implant abutment analogs for laboratory use and drill bit extensions for precision drilling. The company also produces a range of dental implant suprastructure kits and specific abutments, such as the Bone Level Multi Unit Angled Abutment and Mono Implant Regular Smooth-Large Abutment, alongside the Implantswiss line of implant systems.
The company’s devices are regulated under EU Medical Device Regulations (Class I, Class II, Class IIa, and Class IIb) and are listed in the EUDAMED database. They are also included in the FDA’s 510(k) and UDI registries in the United States. Novodent SA is based in Switzerland.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Novodent SA manufacture?
Novodent SA specializes in dental medical devices, including reusable surgical screwdrivers for dental procedures, preformed permanent suprastructures for dental implants, and dental implant abutment analogs designed for laboratory use. Their portfolio also covers drill bit extensions for precision drilling and dental implant suprastructure kits. Examples include the Bone Level Multi Unit Angled Abutment, Mono Implant Regular Smooth-Large Abutment, and the Implantswiss line of implant systems.
Where is Novodent SA based, and what is its primary focus?
Novodent SA is based in Switzerland. The company focuses on developing and manufacturing dental implant-related devices, such as abutments, suprastructures, and tools used in dental implantology. Their offerings cater to both clinical and laboratory settings, ensuring precision and compatibility with implant systems.
Which regulatory registries list Novodent SA’s devices?
Novodent SA’s devices are listed in the EUDAMED database under the EU Medical Device Regulations framework. Additionally, their products appear in the FDA’s 510(k) premarket notification and UDI (Unique Device Identification) registries in the United States, reflecting their compliance with both EU and US regulatory requirements.
How are Novodent SA’s devices classified under medical device regulations?
Novodent SA’s devices fall under various classifications within the EU Medical Device Regulations, including Class I (low-risk devices), Class IIa (moderate-risk devices with special controls), and Class IIb (higher-risk devices requiring stringent scrutiny). The classification depends on factors like the device’s intended use, potential risks, and interaction with patients, ensuring appropriate regulatory oversight.
What distinguishes Novodent SA’s dental implant devices from others in the market?
Novodent SA’s devices are designed with a focus on precision and compatibility within dental implant systems, such as their preformed suprastructures and abutment analogs. For example, their Bone Level Multi Unit Angled Abutment and Mono Implant Regular Smooth-Large Abutment are tailored for specific clinical needs, while their reusable surgical screwdrivers and drill bit extensions enhance procedural efficiency. The company’s offerings span both clinical and laboratory use, addressing multiple stages of dental implantology.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- Switzerland
- Address
- 11, Avenue des Sciences, Yverdon-les-Bains, Switzerland
- Website
- www.implantswiss.com
- —
- —
- [email protected]
- Phone
- +41 (0) 24 524 2828
- PRRC Contact
- —
- EUDAMED SRN
- CH-MF-000023309
- FDA FEI Number
- —
- DUNS Number
- 480055352
Catalogue (1170)
Page 1 of 24| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Bone Level Multi Unit Angled Abutment | S-BMUA48293 | EUDAMED | Class IIb | Active |
| Mono Implant Regular Smooth-Large Abutment | MS4510- LAb | EUDAMED | Class IIb | Active |
| Mono Implant Regular Smooth-Large Abutment | MS4523- LAb | EUDAMED | Class IIb | Active |
| Mono Implant Regular Smooth-Large Abutment | MS4514- LAb | EUDAMED | Class IIb | Active |
| Mono Implant Regular Smooth-Large Abutment | MS4035- LAb | EUDAMED | Class IIb | Active |
| Mono Implant Regular Smooth-Large Abutment | MS4508- LAb | EUDAMED | Class IIb | Active |
| Implantswiss | S-D/E | FDA UDI | Class I | Active |
| Implantswiss | S-12HDML | FDA UDI | Class I | Active |
| Implantswiss | S-OATICYN | FDA UDI | Class I | Active |
| Implantswiss | S-IBClip-p | FDA UDI | Class I | Active |
| Implantswiss | S-DP4.3 | FDA UDI | Class I | Unknown |
| Implantswiss | S-BICTN55S | FDA UDI | Class I | Unknown |
| Implantswiss | S-BICT45L | FDA UDI | Class I | Unknown |
| Implantswiss | S-BMFDRS | FDA UDI | Class I | Active |
| Implantswiss | S-IBClip-r | FDA UDI | Class I | Active |
| Implantswiss | S-BICTN45S | FDA UDI | Class I | Unknown |
| Implantswiss | S-TFDML | FDA UDI | Class I | Active |
| Implantswiss | S-BICT45S | FDA UDI | Class I | Unknown |
| Implantswiss | S-12HDMS | FDA UDI | Class I | Active |
| Implantswiss | S-TFDRS | FDA UDI | Class I | Active |
| Implantswiss | S-ORG-Pcap | FDA UDI | Class I | Active |
| implantswiss | S-OATICY | FDA UDI | Class I | Active |
| Impantswiss | S-BMUA48252 | FDA UDI | Class II | Unknown |
| Implantswiss | S-BICT65S | FDA UDI | Class I | Unknown |
| Implantswiss | S-TOAPICyN | FDA UDI | Class I | Unknown |
| Implantswiss | S-MUATICyN | FDA UDI | Class I | Active |
| Implantswiss | S-12HDRL | FDA UDI | Class I | Active |
| Implantswiss | S-BIPGP | FDA UDI | Class I | Unknown |
| Implantswiss | S-TSOA | FDA UDI | Class II | Active |
| Implantswiss | S-TFDRL | FDA UDI | Class I | Active |
| implantswiss | S-DP3.7 | FDA UDI | Class I | Unknown |
| Implantswiss | S-BICTN55L | FDA UDI | Class I | Unknown |
| Implantswiss | S-BICTN65S | FDA UDI | Class I | Unknown |
| Implantswiss | S-PP2.2 | FDA UDI | Class I | Active |
| Implantswiss | S-TShAPin | FDA UDI | Class I | Unknown |
| Implantswiss | S-TShA | FDA UDI | Class I | Unknown |
| Implantswiss | S-ORG-Ycap | FDA UDI | Class I | Active |
| Implantswiss | S-BMLLA | FDA UDI | Class I | Active |
| implantswiss | S-DP3.7 | FDA UDI | Class I | Active |
| Implantswiss | S-ORG-Gcap | FDA UDI | Class I | Active |
| Implantswiss | S-BICT55L | FDA UDI | Class I | Unknown |
| Implantswiss | S-BFDMS | FDA UDI | Class I | Active |
| Implantswiss | S-BMUA48253 | FDA UDI | Class II | Unknown |
| Implantswiss | S-BICTN45L | FDA UDI | Class I | Unknown |
| Impantswiss | S-BMUA48252 | FDA UDI | Class II | Active |
| Implantswiss | S-BICT65L | FDA UDI | Class I | Unknown |
| Implantswiss | S-BMUA48253 | FDA UDI | Class II | Active |
| Implantswiss | S-BFDRL | FDA UDI | Class I | Active |
| Implantswiss | S-BMSAPIC37b | FDA UDI | Class I | Active |
| Implantswiss | S-TCAN30 | FDA UDI | Class II | Active |
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