FDA Registration
Active
🇦🇹 Austria
W&H DENTALWERK BUERMOOS GMBH - SITE 2
Reg #: 3011300255
·
FEI: 3011300255
·
Expires 2026
Products
26
Proprietary Names
0
Establishment Types
4
Classifications
26
Registration Details
- Registration Name
- W&H DENTALWERK BUERMOOS GMBH - SITE 2
- Registration Number
- 3011300255
- FEI Number
- 3011300255
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- WERNER-BADER-STRASSE 1
- City
- BUERMOOS Salzburg
- Country
- AT
Regulatory Submissions
- 510(k) Number
- K201703
Owner / Operator
- Firm Name
- W&H Dentalwerk Buermoos GmbH
- Operator Number
- 9032044
- Address
- Ignaz-Glaser-Strasse 53, --
- City
- BUERMOOS
- State
- Salzburg
- Postal Code
- 5111
- Country
- AT
- Correspondent
- Gerhard Weidler
US Agent
- Business Name
- MEDAGENT Inc.
- Contact Name
- Franz Menean
- Address
- 264 Lafayette Rd Ste 7
- City
- Portsmouth
- State
- NH
- ZIP
- 03801
- Country
- US
- [email protected]
- Phone
- 603 5702039
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Handpiece, Rotary Bone Cutting | KMW | Class 2 | Dental | No | 2013-01-31 |
| Blade, Saw, General & Plastic Surgery, Surgical | GFA | Class 1 | General, Plastic Surgery | No | 2025-09-02 |
| Scaler, Ultrasonic | ELC | Class 2 | Dental | No | 2013-01-31 |
| Saw, Powered, And Accessories | HAB | Class 1 | General, Plastic Surgery | No | 2018-04-09 |
| Handpiece, Direct Drive, Ac-Powered | EKX | Class 1 | Dental | No | 2021-04-28 |
| Handpiece, Air-Powered, Dental | EFB | Class 1 | Dental | No | 2017-04-20 |
| Drill, Bone, Powered | DZI | Class 2 | Dental | No | 2022-06-21 |
| Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | ERL | Class 2 | Ear, Nose, Throat | No | 2022-06-21 |
| Controller, Foot, Handpiece And Cord | EBW | Class 1 | Dental | No | 2007-12-14 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | Class 1 | General, Plastic Surgery | No | 2008-12-10 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2021-07-20 |
| Activator, Ultraviolet, For Polymerization | EBZ | Class 2 | Dental | No | 2023-07-18 |
| Locator, Root Apex | LQY | Class U | Unknown | No | 2023-07-18 |
| Plugger, Root Canal, Endodontic | EKR | Class 1 | Dental | No | 2023-07-18 |
| Unit, Operative Dental | EIA | Class 1 | Dental | No | 2023-07-18 |
| Handpiece, Belt And/Or Gear Driven, Dental | EFA | Class 1 | Dental | No | 2023-07-18 |
| Cup, Prophylaxis | EHK | Class 1 | Dental | No | 2021-04-28 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2023-02-22 |
| Drills, Burrs, Trephines & Accessories (Simple, Powered) | HBE | Class 2 | Neurology | No | 2023-11-23 |
| Handpiece, Contra- And Right-Angle Attachment, Dental | EGS | Class 1 | Dental | No | 2013-01-31 |
| Instrument, Surgical, Sonic And Accessory/Attachment | JDX | Class 2 | Orthopedic | No | 2025-07-07 |
| Motor, Surgical Instrument, Ac-Powered | GEY | Class 1 | General, Plastic Surgery | No | 1996-01-11 |
| Unit, Oral Irrigation | EFS | Class 1 | Dental | No | 2022-04-19 |
| Bur, Surgical, General & Plastic Surgery | GFF | Class 1 | General, Plastic Surgery | No | 2026-06-02 |
| Accessories, Implant, Dental, Endosseous | NDP | Class 1 | Dental | No | 2006-09-11 |
| Catheter, Irrigation | GBX | Class 1 | General, Plastic Surgery | No | 2024-11-05 |
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility