Manufacturer registered with FDA
Biodenta Swiss AG
Berneck, Switzerland. Lists 3 dental device types with FDA across 1 registered establishment, and holds 11 510(k) clearances as applicant.
- Device types listed
- 3
- Brands and models
- 12
- 510(k) clearances
- 112010–2015
- Markets registered in
- 568 registrations outside the US
- Establishments
- 1Switzerland
510(k) clearances per year, 2007–2026
Registered in 5 markets
Where regulators' registries name Biodenta Swiss AG as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Biodenta Swiss AG | 11 clearances | 2010–2015 | Below |
| Canada | Health Canada | Registration holder | BIODENTA SWISS AG | 40 | 2013–2013 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | BIODENTA SWISS AG | 18 | 2010–2023 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Biodenta Swiss AG | 7 | — | Pure Global AI |
| China | NMPA | Registration holder | 百丹特瑞士股份有限公司Biodenta Swiss AG | 3 | — | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Biodenta Swiss AG currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Root-Form Endosseous ImplantDZE · Class 2 | Dental implants | Maker | Biodenta Dental Implant SystemBiodenta Dental Implant System - Bone Level D 3 to 6 mmBiodenta Dental Implant System (Bone Level Tapered)Biodenta Dental Implant System (Bone Level)Implant, Endosseous, Root-Form - Biodenta Dental Implant System - Bone Level Tapered D 3 and L 6.5 mm | 2010 |
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Maker | Biodenta Customized Abutment - HybridBiodenta Customized Abutment - TitaniumBiodenta Dental Implant System - AbutmentsBiodenta Dental Implant System - Bone Level D 3 to 6 mmBiodenta Dental Implant System - Multi-Use Abutment | 2013 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | Biodenta / DentaSwiss ScanbodyBiodenta Dental Implant System - Surgical and Prosthetic Accessory | 2016 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Biodenta Swiss AG as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 1 Dec 2015 | K151295 | Biodenta Customized Abutment - Titanium | NHA Endosseous Dental Implant Abutment |
| 2 Jul 2015 | K150296 | Biodenta Customized Abutment-Hybrid | NHA Endosseous Dental Implant Abutment |
| 13 Jun 2014 | K133884 | BIODENTA DENTAL IMPLANT SYSTEM-BONE LEVEL TAPERED D3.0 AND L6.5MM | DZE Root-Form Endosseous Implant |
| 30 May 2013 | K123491 | BIODENTA DENTAL IMPLANT SYSTEM - MULTI-USE ABUTMENT | NHA Endosseous Dental Implant Abutment |
| 3 May 2013 | K122559 | BIODENTA DENTAL IMPLANT SYSTEM - ABUTMENTS | NHA Endosseous Dental Implant Abutment |
| 28 Mar 2013 | K123512 | BIODENTA DENTAL IMPLANT SYSTEM- BONE LEVEL D 3.0 TO 6.0 MM | DZE Root-Form Endosseous Implant |
| 19 Mar 2013 | K123415 | BIODENTA DENTAL IMPLANT SYSTEM- BONE LEVEL TAPERED | DZE Root-Form Endosseous Implant |
| 15 Sep 2011 | K111003 | BIODENTA DENTAL IMPLANT SYSTEM - BONE LEVEL | DZE Root-Form Endosseous Implant |
| 29 Jul 2011 | K110778 | BIODENTA CUSTOMIZED ABUTMENT | NHA Endosseous Dental Implant Abutment |
| 3 Jun 2010 | K093630 | BIODENTA DENTAL IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
| 25 May 2010 | K100150 | CERAMICS2IN1 | EIH Porcelain Powder |
Some of these clearances are listed with FDA today by another company: Digital Age Dental Laboratories, Ltd. (2), National Dentex LLC (2).
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| BIODENTA SWISS AGFDA reg. 3008088588 | Berneck Sankt Gallen, Switzerland | Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10030896). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.