W&H DENTALWERK BUERMOOS GMBH - SITE 2

FDA Device Registration & Listing · BUERMOOS Salzburg, AT · Registration 3011300255

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3011300255
FEI Number
3011300255
Entity Name
W&H DENTALWERK BUERMOOS GMBH - SITE 2
City/State/Country
BUERMOOS Salzburg, AT
Establishment Address
WERNER-BADER-STRASSE 1, BUERMOOS Salzburg 5111, AT
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
W&H Dentalwerk Buermoos GmbH (Owner Number: 9032044)
Owner / Operator Contact Address
Ignaz-Glaser-Strasse 53, --, BUERMOOS, AT-5 5111, AT
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KMW Handpiece, Rotary Bone Cutting Dental Class 2 872.4120 2013-01-31
GFA Blade, Saw, General & Plastic Surgery, Surgical General, Plastic Surgery Class 1 878.4820 2025-09-02
ELC Scaler, Ultrasonic Dental Class 2 872.4850 2013-01-31
HAB Saw, Powered, And Accessories General, Plastic Surgery Class 1 878.4820 2018-04-09
EKX Handpiece, Direct Drive, Ac-Powered Dental Class 1 872.4200 2021-04-28
EKX Handpiece, Direct Drive, Ac-Powered Dental Class 1 872.4200 2018-12-11
EFB Handpiece, Air-Powered, Dental Dental Class 1 872.4200 2017-04-20
EFB Handpiece, Air-Powered, Dental Dental Class 1 872.4200 2007-12-14
DZI Drill, Bone, Powered Dental Class 2 872.4120 2022-06-21
ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece Ear, Nose, Throat Class 2 874.4250 2022-06-21
EBW Controller, Foot, Handpiece And Cord Dental Class 1 872.4200 2007-12-14
EBW Controller, Foot, Handpiece And Cord Dental Class 1 872.4200 2007-12-14
EBW Controller, Foot, Handpiece And Cord Dental Class 1 872.4200 2014-11-14
HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment General, Plastic Surgery Class 1 878.4820 2008-12-10
FSM Tray, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2021-07-20
EBZ Activator, Ultraviolet, For Polymerization Dental Class 2 872.6070 2023-07-18
DZI Drill, Bone, Powered Dental Class 2 872.4120 2023-07-18
LQY Locator, Root Apex Unknown Class U N/A 2023-07-18
ELC Scaler, Ultrasonic Dental Class 2 872.4850 2023-07-18
EKR Plugger, Root Canal, Endodontic Dental Class 1 872.4565 2023-07-18
EKX Handpiece, Direct Drive, Ac-Powered Dental Class 1 872.4200 2023-07-18
EIA Unit, Operative Dental Dental Class 1 872.6640 2023-07-18
EFA Handpiece, Belt And/Or Gear Driven, Dental Dental Class 1 872.4200 2023-07-18
EHK Cup, Prophylaxis Dental Class 1 872.6290 2021-04-28
EKX Handpiece, Direct Drive, Ac-Powered Dental Class 1 872.4200 2010-02-03
MDM Instrument, Manual, Surgical, General Use General, Plastic Surgery Class 1 878.4800 2023-02-22
EKX Handpiece, Direct Drive, Ac-Powered Dental Class 1 872.4200 2013-01-31
EBW Controller, Foot, Handpiece And Cord Dental Class 1 872.4200 2016-12-07
EIA Unit, Operative Dental Dental Class 1 872.6640 2023-07-18
EFB Handpiece, Air-Powered, Dental Dental Class 1 872.4200 2016-03-22
EKX Handpiece, Direct Drive, Ac-Powered Dental Class 1 872.4200 2019-06-17
EKX Handpiece, Direct Drive, Ac-Powered Dental Class 1 872.4200 2010-07-12
EFB Handpiece, Air-Powered, Dental Dental Class 1 872.4200 2007-12-14
EFB Handpiece, Air-Powered, Dental Dental Class 1 872.4200 2013-01-31
EFB Handpiece, Air-Powered, Dental Dental Class 1 872.4200 2025-03-03
HBE Drills, Burrs, Trephines & Accessories (Simple, Powered) Neurology Class 2 882.4310 2023-11-23
EGS Handpiece, Contra- And Right-Angle Attachment, Dental Dental Class 1 872.4200 2013-01-31
EFB Handpiece, Air-Powered, Dental Dental Class 1 872.4200 2013-01-31
ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece Ear, Nose, Throat Class 2 874.4250 2025-07-07
DZI Drill, Bone, Powered Dental Class 2 872.4120 2025-07-07
JDX Instrument, Surgical, Sonic And Accessory/Attachment Orthopedic Class 2 888.4580 2025-07-07
HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment General, Plastic Surgery Class 1 878.4820 2025-07-07
GEY Motor, Surgical Instrument, Ac-Powered General, Plastic Surgery Class 1 878.4820 1996-01-11
EFB Handpiece, Air-Powered, Dental Dental Class 1 872.4200 2013-01-31
EBW Controller, Foot, Handpiece And Cord Dental Class 1 872.4200 2007-12-14
EFS Unit, Oral Irrigation Dental Class 1 872.6510 2022-04-19
ELC Scaler, Ultrasonic Dental Class 2 872.4850 2023-07-18
EFB Handpiece, Air-Powered, Dental Dental Class 1 872.4200 2007-12-14

Official Correspondent

Gerhard Weidler

US Agent Details

Franz Menean Business: MEDAGENT Inc. Email: mail@medagent-usa.com Phone: (603) 5702039

Related Public Records

Same Entity

W&H Dentalwerk Buermoos GmbH
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
9681479 W&H DENTALWERK BUERMOOS GMBH BUERMOOS Salzburg, AT

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K953012 Boston Surgical Products, Inc. DISPOSABLE & REUSABLE SURGICAL CUTTING TOOLS 1995-07-12
K832443 California Technics, Inc. ULTRASONIC DENTAL PROPHYLAXIS UNIT 1983-09-12
K994299 Bonart Co., Ltd. ART-P3, MODEL P3-1-ART-A1 2000-03-06
K241065 Dentis Co., Ltd. ChecQ (AC100) 2025-03-21
K212910 Shenzhen Carejoy Technology Co., Ltd. Dental High-speed Turbine Handpiece, Dental Low-speed Turbine Handpiece 2022-11-17

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0027-2016 Zimmer, Inc. 1
Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.

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9681479 W&H DENTALWERK BUERMOOS GMBH BUERMOOS Salzburg, AT
9611253 NAKANISHI INC. Kanuma Tochigi, JP
3009161350 PALTOP ADVANCED DENTAL SOLUTIONS LTD Caesarea Central, IL
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011300255. Last updated year: 2026. Please use registration number 3011300255 when referencing this establishment in official correspondence.
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