Manufacturer registered with FDA
Biotech Dental
Salon de Provence, France. Lists 4 dental device types with FDA across 1 registered establishment, and holds 2 510(k) clearances as applicant.
- Device types listed
- 4
- Brands and models
- 7
- 510(k) clearances
- 22021–2022
- Markets registered in
- 318 registrations outside the US
- Establishments
- 1France
510(k) clearances per year, 2007–2026
Registered in 3 markets
Where regulators' registries name Biotech Dental 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 | Biotech Dental | 2 clearances | 2021–2022 | Below |
| Taiwan | TFDA | Manufacturer | BIOTECH DENTAL S.A.SBIOTECH Dental S.A.S · BIOTECH DENTAL · +1 | 12 | 2007–2023 | Pure Global AI |
| European Union | EUDAMED | Registration holder | Biotech Dental | 6 | — | 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 Biotech Dental 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 | Kontact Dental Implant SystemKontactTM Dental Implant System | 2021 |
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Maker | Kontact Dental Implant SystemKontactTM Dental Implant System | 2021 |
| Powered ToothbrushJEQ · Class 1 | Toothbrushes | Maker | Y-BRUSH | 2026 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | FIX'IN sel-drilling screwKontact Dental Implant System | 2020 |
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 Biotech Dental as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 15 Jul 2022 | K213997 | Kontact Dental Implant System | DZE Root-Form Endosseous Implant |
| 18 Jun 2021 | K210220 | Kontact Dental Implant System | DZE Root-Form Endosseous Implant |
Some of these clearances are listed with FDA today by another company: Biotech Dental (2).
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| BIOTECH DENTAL SASFDA reg. 3014290448 | Salon de Provence Bouches-du-Rhone, France | Complaint file establishment, Manufacturer, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10076527). 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.