Manufacturer registered with FDA
W&H Dentalwerk Buermoos GmbH
BUERMOOS, Austria. Lists 15 dental device types with FDA across 2 registered establishments, and holds 17 510(k) clearances as applicant.
- Device types listed
- 15
- Brands and models
- 0
- 510(k) clearances
- 171999–2026
- Markets registered in
- 412 registrations outside the US
- Establishments
- 2Austria
510(k) clearances per year, 1990–2026
Registered in 4 markets
Where regulators' registries name W&H Dentalwerk Buermoos 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 | Manufacturer | W&H Dentalwerk Buermoos GmbH | 17 clearances | 1999–2026 | Below |
| Saudi Arabia | SFDA | Manufacturer | W&H Dentalwerk Buermoos GmbH | 7 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | W & H Dentalwerk Buermoos GmbHW&H Dentalwerk Buermoos GmbH | 3 | 2001–2002 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | W&H DENTALWERK BUERMOOS GMBH | 2 | 2014–2014 | 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 W&H Dentalwerk Buermoos GmbH currently lists, by FDA device type, with the brand and model names on the listing.
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 W&H Dentalwerk Buermoos GmbH as the applicant, including filings under its other names.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 18 Jun 2026 | K253776 | Implantmed Plus II & Piezomed Plus II Module | DZI Powered Bone Drill |
| 24 Feb 2021 | K201703 | PROXEO Twist Cordless Polishing System PL-40 H | EKX Ac-Powered Direct Drive Handpiece |
| 26 Mar 2019 | K181858 | Electric Handpiece Motor | EBW Handpiece and Cord Foot Controller |
| 8 Dec 2017 | K171553 | W&H Assistina Twin | EFB Dental Air-Powered Handpiece |
| 23 Nov 2015 | K143704 | Advanced Air System | EFB Dental Air-Powered Handpiece |
| 16 Oct 2014 | K133488 | PIEZOMED | DZI Powered Bone Drill |
| 9 Jul 2010 | K100600 | PROSTHODONTIC SCREWDRIVER , MODEL IA-400 | EKX Ac-Powered Direct Drive Handpiece |
| 14 Jan 2010 | K083811 | W&H HANDPIECE ANESTO, MODEL: RA-5 | EGM Mechanical-Powered Jet Injector |
| 15 Dec 2009 | K090931 | CORDLESS ENDO HANDPIECES EB-300, ENTRAN AND EB-300 S, S5 ENDO MOTOR | EKX Ac-Powered Direct Drive Handpiece |
| 30 Jun 2009 | K090548 | CONTRA-ANGLE HANDPIECE KOMET OS30 | EFB Dental Air-Powered Handpiece |
| 29 Jul 2008 | K080939 | SURGICAL HANDPIECES, MIKRO SAW HANDPIECES | KMW Rotary Bone Cutting Handpiece |
| 3 May 2006 | K060287 | DRILLTECH, ISM, IMPLANTUNIT, ZIMMER SURGICAL MOTOR SYSTEM | EBW Handpiece and Cord Foot Controller |
| 13 Jan 2006 | K052741 | IMPLANTMED SI-915 (115V VERSION); IMPLANTMED SI-923 (230V VERSION) INCL. ACCESSORIES | EBW Handpiece and Cord Foot Controller |
| 3 May 2002 | K014068 | ELCOMED, MODELS SA-200 C 230, SA-200 230, SA-200 C 115, SA-200 115 | EBW Handpiece and Cord Foot Controller |
| 28 Jun 2001 | K011061 | SURGICAL CONTRA-ANGEL HANDPIECES TYPES WS-56E,WS-75E/KM,WS-92 E/3,SURGICAL STRAIGHT HANDPIECES TYPES, S-9, S-10, S-11 | EGS Dental Contra- and Right-Angle Attachment Handpiece |
| 7 Feb 2001 | K002469 | IMPLANTMED SI-95 115 (100-130 V) AND SI-95 230 (220-240 V) | EBW Handpiece and Cord Foot Controller |
| 25 Jun 1999 | K984508 | SURGICAL CONTRA-ANGLE HANDPIECES, MODELS 975 AE,979 E/KM, 985 AE, 986 AE, 988 E/KM AND SURGICAL STRAIGHT HANDPIECES MOD | DZA Intraoral Dental Drill |
Some of these clearances are listed with FDA today by another company: Dentsply Sirona, Inc. (4), Nobel Biocare Services AG (3), ARTHREX Inc. (2), Peter Brasseler Holdings, LLC (1), Gebr. Brasseler GmbH & Co. KG (1), Bicon, LLC (1).
Also lists devices cleared under other names
W&H Dentalwerk Buermoos GmbH lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: W&H Dentalwerk Bürmoos GmbH (3), Asi Medical, Inc. (2), W&H Dentalwerk Buermoss GmbH (1), Osstell AB (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 31 Jul 2026 | K253655 | Angled Screwdriver MED (M-SD090) | W&H Dentalwerk Bürmoos GmbH | DZI Powered Bone Drill |
| 28 Feb 2025 | K242179 | Synea Fusion Handpieces (Intensiv & Profin) | W&H Dentalwerk Bürmoos GmbH | EFB Dental Air-Powered Handpiece |
| 14 Jul 2023 | K223173 | Proxeo ULTRA (PB-510, PB-520 and PB-530) | W&H Dentalwerk Buermoss GmbH | ELC Ultrasonic Scaler |
| 23 Feb 2017 | K162926 | Air-Powered Handpieces and Handpiece Attachments | W&H Dentalwerk Bürmoos GmbH | EFB Dental Air-Powered Handpiece |
| 9 Apr 2014 | K132401 | MEGA ISQ | Osstell AB | EKX Ac-Powered Direct Drive Handpiece |
| 28 Mar 2013 | K123139 | ADVANCED ENDODONTIC SYSTEM- DESIGNER SERIES | Asi Medical, Inc. | ELC Ultrasonic Scaler |
| 5 Apr 2012 | K110481 | TRITON SELF CONTAINED DENTAL SYSTEM, TRITON SELF CONTAINED DENTAL SYSTEM, WITH CASE | Asi Medical, Inc. | EIA Operative Dental Unit |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| W&H DENTALWERK BUERMOOS GMBHFDA reg. 9681479 | BUERMOOS Salzburg, Austria | Contract manufacturer, Foreign exporter, Manufacturer, Specification developer |
| W&H DENTALWERK BUERMOOS GMBH - SITE 2FDA reg. 3011300255 | BUERMOOS Salzburg, Austria | Contract manufacturer, Foreign exporter, Manufacturer, Specification developer |
Other names on FDA records
W&H Dentalwerk Buermoos GmbH - Site 2
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9032044). 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.