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Sign in to claim this brandBiodenta Swiss AG
Switzerland·CH-MF-000034374
Last updated September 17, 2026
What Biodenta Swiss AG makes
Biodenta Swiss AG manufactures dental implant suprastructures (both permanent and temporary, preformed), surgical drill guides (single-use), two-piece screw endosteal dental implants, dental implant abutment analogs for intraoral scanning (single-use), and dental prosthesis/implant abutment screws.
These devices are classified as Class I, Class II, and Class IIb and are listed in Eudamed, FDA 510(k), and FDA UDI databases. The company is based in Switzerland (CH).
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What does Biodenta Swiss AG manufacture?
Biodenta Swiss AG manufactures dental implant suprastructures (both permanent and temporary, preformed), surgical drill guides (single-use), two-piece screw endosteal dental implants, dental implant abutment analogs for intraoral scanning (single-use), and dental prosthesis/implant abutment screws. These are the specific device types described in the provided data, and no other products or functions are attributed to the company in this source.
Where is Biodenta Swiss AG based?
Biodenta Swiss AG is based in Switzerland, as indicated by the country code CH in the device data. This establishes the company’s geographic location without implying any regulatory approval or certification of the company itself.
Which regulatory registries list devices from Biodenta Swiss AG?
Devices from Biodenta Swiss AG are listed in Eudamed, the FDA 510(k) database, and the FDA UDI database. These are the only registries explicitly named in the provided data, and listing in these systems reflects device registration, not company approval.
How are the devices manufactured by Biodenta Swiss AG classified?
The devices manufactured by Biodenta Swiss AG are classified as Class I, Class II, and Class IIb. This classification reflects the risk-based regulatory categorization of the individual device types, such as surgical drill guides or implant abutments, and does not imply that the company as a whole holds any classification or approval.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- Switzerland
- Address
- 16, Tramstrasse, Berneck, Switzerland
- Website
- biodenta.com
- —
- —
- [email protected]
- Phone
- +41 71 747 11 11
- PRRC Contact
- Hebe Hsieh
- EUDAMED SRN
- CH-MF-000034374
- FDA FEI Number
- 3008088588
- DUNS Number
- 484609081
Catalogue (357)
Page 6 of 8| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Biodenta | BL-B035GH2B | FDA UDI | Class II | Active |
| DentaSwiss | SI-G200E00S | FDA UDI | Class I | Active |
| DentaSwiss | GS-36NEGNR | FDA UDI | Class I | Active |
| DentaSwiss | GS-36NB4NP | FDA UDI | Class I | Active |
| DentaSwiss | GS-36KPP41 | FDA UDI | Class I | Active |
| Biodenta | AB-B150GH2A | FDA UDI | Class II | Active |
| DentaSwiss | GS-36ZMR24 | FDA UDI | Class I | Active |
| Biodenta | I-PA30B0L14A | FDA UDI | Class II | Active |
| DentaSwiss | SI-G150E00S | FDA UDI | Class I | Active |
| Biodenta | AB-B140GH2A | FDA UDI | Class II | Active |
| Biodenta | CAD-THASBLNCS | FDA UDI | Class II | Active |
| Biodenta | I-PA35B1L14A | FDA UDI | Class II | Active |
| Biodenta | CAD-TPNRRPWS | FDA UDI | Class II | Active |
| Biodenta | CAD-CASOTS35 | FDA UDI | Class II | Active |
| DentaSwiss | CAD-TSBBH57S | FDA UDI | Class I | Active |
| DentaSwiss | GS-360PL16 | FDA UDI | Class I | Active |
| Biodenta | CAD-CUSTITAN | FDA UDI | Class II | Active |
| DentaSwiss | GS-36KPP51 | FDA UDI | Class I | Active |
| DentaSwiss | GS-36ZMR53 | FDA UDI | Class I | Active |
| Biodenta | I-BA60B2L12A | FDA UDI | Class II | Active |
| Biodenta | AB-B150GH2N | FDA UDI | Class II | Active |
| DentaSwiss | GS-36ZMR35 | FDA UDI | Class I | Active |
| Biodenta | I-PA48B2L08A | FDA UDI | Class II | Active |
| DentaSwiss | GS-LTBM50YE | FDA UDI | Class I | Active |
| Biodenta | AB-B260GH2N | FDA UDI | Class II | Active |
| DentaSwiss | CAD-TSBZSV35S | FDA UDI | Class I | Active |
| DentaSwiss | GS-LTBM41BL | FDA UDI | Class I | Active |
| DentaSwiss | CAD-TSBB3I456S | FDA UDI | Class I | Active |
| DentaSwiss | CAD-TSBNRWPS | FDA UDI | Class I | Active |
| DentaSwiss | CAD-TSBOTRS | FDA UDI | Class I | Active |
| DentaSwiss | GS-36GEN41 | FDA UDI | Class I | Active |
| DentaSwiss | GS-36NB5RP | FDA UDI | Class I | Active |
| DentaSwiss | GS-36BHZ51G | FDA UDI | Class I | Active |
| DentaSwiss | GS-36AEV52 | FDA UDI | Class I | Active |
| Universal Analog | CAD-UA3ICI34 | EUDAMEDFDA UDI | Class I | Active |
| Scanbody | CAD-SB3IC4156 | EUDAMEDFDA UDI | Class I | Active |
| Universal Analog | CAD-UANMUNRW | EUDAMEDFDA UDI | Class I | Active |
| Straight Abutment | AB-B040GH2N | EUDAMEDFDA UDI | Class IIb | Active |
| Scanbody | CAD-SBBBLB0 | EUDAMED | Class I | Active |
| Universal Analog | CAD-UABHI35 | EUDAMEDFDA UDI | Class I | Active |
| Scanbody | CAD-SBNBRPI | EUDAMEDFDA UDI | Class I | Active |
| Biodenta Customized Abutment-Hybrid | K150296 | FDA 510(k) | Class II | Active |
| Biodenta Dental Implant System - Multi-Use Abutment | K123491 | FDA 510(k) | Class II | Active |
| Biodenta Dental Implant System | K093630 | FDA 510(k) | Class II | Active |
| Ceramics2in1 | K100150 | FDA 510(k) | Class II | Active |
| Biodenta Dental Implant System- Bone Level D 3.0 To 6.0 Mm | K123512 | FDA 510(k) | Class II | Active |
| Biodenta Dental Implant System-Bone Level Tapered D3.0 And L6.5mm | K133884 | FDA 510(k) | Class II | Active |
| Biodenta Customized Abutment - Titanium | K151295 | FDA 510(k) | Class II | Active |
| Biodenta Dental Implant System - Bone Level | K111003 | FDA 510(k) | Class II | Active |
| Biodenta Dental Implant System- Bone Level Tapered | K123415 | FDA 510(k) | Class II | Active |
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