W & H DentalWerk Buermoos GmbH
BUERMOOS Salzburg, AT
W&H DENTALWERK BUERMOOS GMBH appears in FDA device records in BUERMOOS Salzburg, AT. FDA records list 18 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 3 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to W & H DentalWerk Buermoos GmbH carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- W & H DentalWerk Burmoos GMBH - Site 1enforcement report, recall
510(k) clearance history
FDA records hold 18 510(k) clearances for W & H DentalWerk Buermoos GmbH between 1999 and 2026. The busiest year on record is 2001, with 2. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1999 | 1 |
| 2001 | 2 |
| 2002 | 1 |
| 2006 | 2 |
| 2008 | 1 |
| 2009 | 2 |
| 2010 | 2 |
| 2014 | 1 |
| 2015 | 1 |
| 2017 | 1 |
| 2019 | 1 |
| 2021 | 1 |
| 2025 | 1 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K253776 | Implantmed Plus II & Piezomed Plus II Module | DZI | Substantially Equivalent | |
| K243280 | Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350, Piezomed Pro instruments (various tips) and accessories) | ERL | Substantially Equivalent | |
| K201703 | PROXEO Twist Cordless Polishing System PL-40 H | EKX | Substantially Equivalent | |
| K181858 | Electric Handpiece Motor | EBW | Substantially Equivalent | |
| K171553 | W&H Assistina Twin | EFB | Substantially Equivalent | |
| K143704 | Advanced Air System | EFB | Substantially Equivalent | |
| K133488 | PIEZOMED | DZI | Substantially Equivalent | |
| K100600 | PROSTHODONTIC SCREWDRIVER , MODEL IA-400 | EKX | Substantially Equivalent | |
| K083811 | W&H HANDPIECE ANESTO, MODEL: RA-5 | EGM | Substantially Equivalent | |
| K090931 | CORDLESS ENDO HANDPIECES EB-300, ENTRAN AND EB-300 S, S5 ENDO MOTOR | EKX | Substantially Equivalent | |
| K090548 | CONTRA-ANGLE HANDPIECE KOMET OS30 | EFB | Substantially Equivalent | |
| K080939 | SURGICAL HANDPIECES, MIKRO SAW HANDPIECES | KMW | Substantially Equivalent | |
| K060287 | DRILLTECH, ISM, IMPLANTUNIT, ZIMMER SURGICAL MOTOR SYSTEM | EBW | Substantially Equivalent | |
| K052741 | IMPLANTMED SI-915 (115V VERSION); IMPLANTMED SI-923 (230V VERSION) INCL. ACCESSORIES | EBW | Substantially Equivalent | |
| K014068 | ELCOMED, MODELS SA-200 C 230, SA-200 230, SA-200 C 115, SA-200 115 | EBW | Substantially Equivalent | |
| 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 | Substantially Equivalent | |
| K002469 | IMPLANTMED SI-95 115 (100-130 V) AND SI-95 230 (220-240 V) | EBW | Substantially Equivalent | |
| K984508 | SURGICAL CONTRA-ANGLE HANDPIECES, MODELS 975 AE,979 E/KM, 985 AE, 986 AE, 988 E/KM AND SURGICAL STRAIGHT HANDPIECES MOD | DZA | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 9681479 | 3003755849 | W&H DENTALWERK BUERMOOS GMBH | 53 IGNAZ-GLASER-STRASSE, BUERMOOS Salzburg 5111 AT | 2026 | and 17 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- NDPAccessories, Implant, Dental, Endosseous
- EBZActivator, Ultraviolet, For Polymerization
- GFABlade, Saw, General & Plastic Surgery, Surgical
- GFFBur, Surgical, General & Plastic Surgery
- GBXCatheter, Irrigation
- EBWController, Foot, Handpiece And Cord
- EHKCup, Prophylaxis
- DZIDrill, Bone, Powered
- DZADrill, Dental, Intraoral
- ERLDrill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
- HBEDrills, Burrs, Trephines & Accessories (Simple, Powered)
- DZJDriver, Wire, And Bone Drill, Manual
- EFBHandpiece, Air-Powered, Dental
- EFAHandpiece, Belt And/Or Gear Driven, Dental
- EGSHandpiece, Contra- And Right-Angle Attachment, Dental
- EKXHandpiece, Direct Drive, Ac-Powered
- KMWHandpiece, Rotary Bone Cutting
- EGMInjector, Jet, Mechanical-Powered
- MDMInstrument, Manual, Surgical, General Use
- HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
- JDXInstrument, Surgical, Sonic And Accessory/Attachment
- LQYLocator, Root Apex
- GEYMotor, Surgical Instrument, Ac-Powered
- EKRPlugger, Root Canal, Endodontic
- HABSaw, Powered, And Accessories
- ELCScaler, Ultrasonic
- FSMTray, Surgical, Instrument
- EIAUnit, Operative Dental
- EFSUnit, Oral Irrigation
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1168-2024 | W&H Surgical handpiece S-12. For Surgical treatment of dental hard tissue Model Number: 30061000 | 1:2 speed increasing surgical handpieces have been incorrectly laser marked during production. The specific laser marking should read 1:2, but instead it reads 1:1 on the body of the handpiece | Class II | Open, Classified | |
| Z-1351-2018 | Foot Controls Model: S-N1 and S-N2 Product Usage: Variable foot control for use with drive units operating mechanical instruments. | During continuous postmarket surveillance activities, we have noticed a potential malfunction of individual foot controls of the type S-N1/S-N2. In case the error occurs, the foot control might not switch back to zero position when the pedal is released. Consequently, the motor keeps rotating. If this happens during automatic thread cutting or automatic screwing-in of implants, it may, in the worst case, lead to a serious injury of the patient. | Class II | Terminated | |
| Z-2879-2011 | Arthrex Reciprocating Saw Attachment Type: V-600SR Distributed by: Arthrex Inc., Naples, Florida United States The system Is a modular electric system, consisting of a handpiece drive, various accessories, and a charging station for machining bones. It can be used in the following areas of application: orthopaedic and A&E Interventions, such as osteotomies, large and small bone operations, and joint replacement operations. The charging station is intended exclusively for charging V 600 Li-Ion and V 300 LiIon rechargeable batteries | Reciprocating saw attachment V 600 Sr (REF: 17306210), screws can become loose or come off (the attachment) and fall into the surgical wound and may not be noticed due to its small size. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain