Not currently registered with FDA under this name
W&H Dentalwerk Bürmoos GmbH
Buermoos, Austria. Named as applicant on 5 dental 510(k) clearances between 2004 and 2026. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 52004–2026
- Markets registered in
- 171,160 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 2000–2026
Registered in 17 markets
Where regulators' registries name W&H Dentalwerk Bürmoos GmbH as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Applicant | W&H Dentalwerk Bürmoos GmbH | 5 clearances | 2004–2026 | Below |
| Canada | Health Canada | Registration holder | W&H DENTALWERK BURMOOS GMBH | 638 | 1998–2026 | Pure Global AI |
| South Korea | MFDS | Manufacturer | W&H Dentalwerk Burmoos GmbHW&H Dentalwerk Burmoos GmbH. · W & H Dentalwerk Burmoos GmbH · +2 | 93 | 1998–2026 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | W & H Dentalwerk Bürmoos GmbH | 79 | — | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | W&H Dentalwerk Burmoos GmbH | 70 | — | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | W&H Dentalwerk Bürmoos GmbHW&H Dentalwerk Burmoos GmbH · W&H DENTALWERK BURMOOS GMBH | 65 | — | Pure Global AI |
| Australia | TGA | Manufacturer | W & H Dentalwerk Burmoos GmbH | 41 | 2003–2026 | Pure Global AI |
| Serbia | ALIMS | Manufacturer | W & H Dentalwerk Burmoos GmbH | 39 | 2021–2026 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | W&H Dentalwerk Bürmoos GmbHW & H DENTALWERK BURMOOS GMBH · W&H DENTALWERK BURMOOS GMBH | 35 | 2005–2026 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | W&H Dentalwerk Burmoos GmbH | 30 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | W&H DENTALWERK BÜRMOOS GmbHW & H DENTALWERK BÜRMOOS GmbH · W & H DENTALWERK BURMOOS GMBH · +2 | 20 | 2015–2025 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | W&H DENTALWERK BÜRMOOS GMBHW&H DENTALWERK BURMOOS G.M.B.H | 16 | 2011–2025 | Pure Global AI |
| China | NMPA | Registration holder | 伟合牙科设备有限责任公司W&H Dentalwerk Bürmoos GmbH | 14 | — | Pure Global AI |
| Hong Kong | MDD | Manufacturer | W&H Dentalwerk Bürmoos GmbHW & H Dentalwerk Bürmoos GmbH | 9 | 2025–2026 | Pure Global AI |
| Japan | PMDA | Registration holder | Ｗ＆Ｈ Ｄｅｎｔａｌｗｅｒｋ Ｂｕ（¨）ｒｍｏｏｓ ＧｍｂＨ | 5 | 2021–2022 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | W&H DENTALWERK BURMOOS GMBHW & H DENTAL WERK BURMOOS GMBH | 3 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | W&H Dentalwerk Burmoos GmbH | 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
510(k) clearances
Clearances on which FDA names W&H Dentalwerk Bürmoos GmbH as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 31 Jul 2026 | K253655 | Angled Screwdriver MED (M-SD090) | DZI Powered Bone Drill |
| 28 Feb 2025 | K242179 | Synea Fusion Handpieces (Intensiv & Profin) | EFB Dental Air-Powered Handpiece |
| 23 Feb 2017 | K162926 | Air-Powered Handpieces and Handpiece Attachments | EFB Dental Air-Powered Handpiece |
| 23 Nov 2016 | K161957 | W&H Implantmed SI-1015 incl. Accessories | EBW Handpiece and Cord Foot Controller |
| 7 Jun 2004 | K041124 | IRRIGATION TUBING SET 2.2M AND 3.8M | EBW Handpiece and Cord Foot Controller |
Some of these clearances are listed with FDA today by another company: W&H Dentalwerk Buermoos GmbH (3), Stryker (1), Peter Brasseler Holdings, LLC (1), Gebr. Brasseler GmbH & Co. KG (1), A-dec, Inc. (1), Dentsply Sirona, Inc. (1).
Sources
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 of the most recent filing, which can be a US agent.