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Data / Medical devices / Austria / W&H Dentalwerk Buermoos GMBH - Site 2

W&H Dentalwerk Buermoos GMBH - Site 2: FDA-registered device maker in BUERMOOS Salzburg, Austria, 23 510(k) clearances

W&H Dentalwerk Buermoos GMBH - Site 2 is registered with the FDA (registration 3011300255) in BUERMOOS Salzburg, Austria. It lists 27 device types. The FDA files 23 510(k) clearances under its listings, the newest dated July 31, 2026. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

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FDA registration number
3011300255
Address
Werner-Bader-Strasse 1, BUERMOOS Salzburg, Austria, 5111
Owner or operator
W&H Dentalwerk Buermoos GmbH (9032044)
Roles
Contract manufacturer, Exporter to the US, Manufacturer, Specification developer
First device listed
January 11, 1996
Registered through
2026

Devices it lists

DeviceProduct codeClassRoleSource
Accessories, Implant, Dental, EndosseousNDP1Contract manufactureraccessdata.fda.gov
Activator, Ultraviolet, For PolymerizationEBZ2Exporter to the US, Manufactureraccessdata.fda.gov
Blade, Saw, General & Plastic Surgery, SurgicalGFA1Exporter to the USaccessdata.fda.gov
Bur, Surgical, General & Plastic SurgeryGFF1Exporter to the USaccessdata.fda.gov
Catheter, IrrigationGBX1Exporter to the USaccessdata.fda.gov
Controller, Foot, Handpiece And CordEBW1Contract manufacturer, Manufactureraccessdata.fda.gov
Cup, ProphylaxisEHK1Exporter to the USaccessdata.fda.gov
Drill, Bone, PoweredDZI2Exporter to the US, Manufactureraccessdata.fda.gov
Drill, Surgical, Ent (Electric Or Pneumatic) Including HandpieceERL2Manufactureraccessdata.fda.gov
Drills, Burrs, Trephines & Accessories (Simple, Powered)HBE2Contract manufactureraccessdata.fda.gov
Driver, Wire, And Bone Drill, ManualDZJ2Exporter to the US, Manufactureraccessdata.fda.gov
Handpiece, Air-Powered, DentalEFB1Contract manufacturer, Manufacturer, Specification developeraccessdata.fda.gov
Handpiece, Belt And/Or Gear Driven, DentalEFA1Exporter to the US, Manufactureraccessdata.fda.gov
Handpiece, Contra- And Right-Angle Attachment, DentalEGS1Contract manufacturer, Manufactureraccessdata.fda.gov
Handpiece, Direct Drive, Ac-PoweredEKX1Contract manufacturer, Exporter to the US, Manufactureraccessdata.fda.gov
Handpiece, Rotary Bone CuttingKMW2Contract manufacturer, Manufactureraccessdata.fda.gov
Instrument, Manual, Surgical, General UseMDM1Contract manufacturer, Manufactureraccessdata.fda.gov
Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/AttachmentHWE1Contract manufacturer, Exporter to the US, Manufactureraccessdata.fda.gov
Instrument, Surgical, Sonic And Accessory/AttachmentJDX2Manufactureraccessdata.fda.gov
Locator, Root ApexLQYUExporter to the US, Manufactureraccessdata.fda.gov
Motor, Surgical Instrument, Ac-PoweredGEY1Contract manufacturer, Manufactureraccessdata.fda.gov
Plugger, Root Canal, EndodonticEKR1Exporter to the US, Manufactureraccessdata.fda.gov
Saw, Powered, And AccessoriesHAB1Contract manufactureraccessdata.fda.gov
Scaler, UltrasonicELC2Contract manufacturer, Exporter to the US, Manufactureraccessdata.fda.gov
Tray, Surgical, InstrumentFSM1Exporter to the USaccessdata.fda.gov
Unit, Operative DentalEIA1Exporter to the US, Manufactureraccessdata.fda.gov
Unit, Oral IrrigationEFS1Exporter to the USaccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
July 31, 2026K253655Angled Screwdriver MED (M-SD090)DZISubstantially EquivalentW&H Dentalwerk Bürmoos GmbHaccessdata.fda.gov
June 18, 2026K253776Implantmed Plus II & Piezomed Plus II ModuleDZISubstantially EquivalentW&H Dentalwerk Buermoos GmbHaccessdata.fda.gov
July 3, 2025K243280Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350, Piezomed Pro instruments (various tips) and accessories)ERLSubstantially EquivalentW&H Dentalwerk Buermoos GmbHaccessdata.fda.gov
February 28, 2025K242179Synea Fusion Handpieces (Intensiv & Profin)EFBSubstantially EquivalentW&H Dentalwerk Bürmoos GmbHaccessdata.fda.gov
July 14, 2023K223173Proxeo ULTRA (PB-510, PB-520 and PB-530)ELCSubstantially EquivalentW&H Dentalwerk Buermoss GmbHaccessdata.fda.gov
May 26, 2022K213221AMADEO, M-UK1015 (incl. attachments and accessories)ERLSubstantially EquivalentW&H Dentalwerk Buermoss GmbHaccessdata.fda.gov
February 24, 2021K201703PROXEO Twist Cordless Polishing System PL-40 HEKXSubstantially EquivalentW&H Dentalwerk Buermoos GmbHaccessdata.fda.gov
March 26, 2019K181858Electric Handpiece MotorEBWSubstantially EquivalentW&H Dentalwerk Buermoos GmbHaccessdata.fda.gov
December 8, 2017K171553W&H Assistina TwinEFBSubstantially EquivalentW&H Dentalwerk Buermoos GmbHaccessdata.fda.gov
February 23, 2017K162926Air-Powered Handpieces and Handpiece AttachmentsEFBSubstantially EquivalentW&H Dentalwerk Burmoos GmbHaccessdata.fda.gov
November 23, 2015K143704Advanced Air SystemEFBSubstantially EquivalentW&H Dentalwerk Buermoos GmbHaccessdata.fda.gov
October 16, 2014K133488PIEZOMEDDZISubstantially EquivalentW&H Dentalwerk Buermoos GmbHaccessdata.fda.gov
April 9, 2014K132401MEGA ISQEKXSubstantially EquivalentOsstell ABaccessdata.fda.gov
March 28, 2013K123139ADVANCED ENDODONTIC SYSTEM- DESIGNER SERIESELCSubstantially EquivalentAsi Medical, Inc.accessdata.fda.gov
April 5, 2012K110481TRITON SELF CONTAINED DENTAL SYSTEM, TRITON SELF CONTAINED DENTAL SYSTEM, WITH CASEEIASubstantially EquivalentAsi Medical, Inc.accessdata.fda.gov
July 9, 2010K100600PROSTHODONTIC SCREWDRIVER , MODEL IA-400EKXSubstantially EquivalentW&H Dentalwerk Buermoos GmbHaccessdata.fda.gov
December 15, 2009K090931CORDLESS ENDO HANDPIECES EB-300, ENTRAN AND EB-300 S, S5 ENDO MOTOREKXSubstantially EquivalentW&H Dentalwerk Buermoos GmbHaccessdata.fda.gov
June 30, 2009K090548CONTRA-ANGLE HANDPIECE KOMET OS30EFBSubstantially EquivalentW&H Dentalwerk Buermoos GmbHaccessdata.fda.gov
July 29, 2008K080939SURGICAL HANDPIECES, MIKRO SAW HANDPIECESKMWSubstantially EquivalentW&H Dentalwerk Buermoos GmbHaccessdata.fda.gov
May 3, 2006K060287DRILLTECH, ISM, IMPLANTUNIT, ZIMMER SURGICAL MOTOR SYSTEMEBWSubstantially EquivalentW&H Dentalwerk Buermoos GmbHaccessdata.fda.gov
May 3, 2002K014068ELCOMED, MODELS SA-200 C 230, SA-200 230, SA-200 C 115, SA-200 115EBWSubstantially EquivalentW&H Dentalwerk Buermoos GmbHaccessdata.fda.gov
June 28, 2001K011061SURGICAL CONTRA-ANGEL HANDPIECES TYPES WS-56E,WS-75E/KM,WS-92 E/3,SURGICAL STRAIGHT HANDPIECES TYPES, S-9, S-10, S-11EGSSubstantially EquivalentW&H Dentalwerk Buermoos GmbHaccessdata.fda.gov
February 7, 2001K002469IMPLANTMED SI-95 115 (100-130 V) AND SI-95 230 (220-240 V)EBWSubstantially EquivalentW&H Dentalwerk Buermoos GmbHaccessdata.fda.gov

Compare with other makers

Updated July 31, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.