FDA Registration
Active
🇦🇹 Austria
W&H DENTALWERK BUERMOOS GMBH
Reg #: 9681479
·
FEI: 3003755849
·
Expires 2025
Products
8
Proprietary Names
0
Establishment Types
2
Classifications
8
Registration Details
- Registration Name
- W&H DENTALWERK BUERMOOS GMBH
- Registration Number
- 9681479
- FEI Number
- 3003755849
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 53 IGNAZ-GLASER-STRASSE
- City
- BUERMOOS Salzburg
- Country
- AT
Regulatory Submissions
- 510(k) Number
- K123139
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 |
|---|---|---|---|---|---|
| Locator, Root Apex | LQY | Class U | Unknown | No | 2023-07-18 |
| Scaler, Ultrasonic | ELC | Class 2 | Dental | No | 2023-07-18 |
| Handpiece, Direct Drive, Ac-Powered | EKX | Class 1 | Dental | No | 2023-07-18 |
| Plugger, Root Canal, Endodontic | EKR | Class 1 | Dental | No | 2023-07-18 |
| Activator, Ultraviolet, For Polymerization | EBZ | Class 2 | Dental | No | 2023-07-18 |
| Drill, Bone, Powered | DZI | Class 2 | 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 |
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device