FDA Device Registration & Listing · BUERMOOS Salzburg, AT · Registration 9681479
Normalized identity and public registration information from FDA records.
No proprietary names listed under this establishment.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| 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 |
| EFS | Unit, Oral Irrigation | Dental | Class 1 | 872.6510 | 2022-04-19 |
| EIA | Unit, Operative Dental | Dental | Class 1 | 872.6640 | 2023-07-18 |
| HAB | Saw, Powered, And Accessories | General, Plastic Surgery | Class 1 | 878.4820 | 2018-04-09 |
| EFB | Handpiece, Air-Powered, Dental | Dental | Class 1 | 872.4200 | 2007-12-14 |
| GEY | Motor, Surgical Instrument, Ac-Powered | General, Plastic Surgery | Class 1 | 878.4820 | 1996-01-11 |
| KMW | Handpiece, Rotary Bone Cutting | Dental | Class 2 | 872.4120 | 2013-01-31 |
| 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 |
| ELC | Scaler, Ultrasonic | Dental | Class 2 | 872.4850 | 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 |
| EHK | Cup, Prophylaxis | Dental | Class 1 | 872.6290 | 2021-04-28 |
| HWE | Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | General, Plastic Surgery | Class 1 | 878.4820 | 2008-12-10 |
| EFB | Handpiece, Air-Powered, Dental | Dental | Class 1 | 872.4200 | 2017-12-12 |
| GBX | Catheter, Irrigation | General, Plastic Surgery | Class 1 | 878.4200 | 2024-11-05 |
| EFB | Handpiece, Air-Powered, Dental | Dental | Class 1 | 872.4200 | 2016-03-22 |
| 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 |
| ELC | Scaler, Ultrasonic | Dental | Class 2 | 872.4850 | 2023-07-18 |
| EBW | Controller, Foot, Handpiece And Cord | Dental | Class 1 | 872.4200 | 2019-04-01 |
| NDP | Accessories, Implant, Dental, Endosseous | Dental | Class 1 | 872.3980 | 2006-09-11 |
| EFB | Handpiece, Air-Powered, Dental | Dental | Class 1 | 872.4200 | 2025-03-03 |
| 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 |
| EKX | Handpiece, Direct Drive, Ac-Powered | Dental | Class 1 | 872.4200 | 2010-07-12 |
| EKX | Handpiece, Direct Drive, Ac-Powered | Dental | Class 1 | 872.4200 | 2013-01-31 |
| EKX | Handpiece, Direct Drive, Ac-Powered | Dental | Class 1 | 872.4200 | 2010-02-03 |
| EBW | Controller, Foot, Handpiece And Cord | Dental | Class 1 | 872.4200 | 2007-12-14 |
| EGS | Handpiece, Contra- And Right-Angle Attachment, Dental | Dental | Class 1 | 872.4200 | 2007-12-14 |
| GFF | Bur, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4820 | 2026-06-02 |
| HBE | Drills, Burrs, Trephines & Accessories (Simple, Powered) | Neurology | Class 2 | 882.4310 | 2023-11-23 |
| 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 | 2016-12-07 |
| EBW | Controller, Foot, Handpiece And Cord | Dental | Class 1 | 872.4200 | 2014-11-14 |
| EBW | Controller, Foot, Handpiece And Cord | Dental | Class 1 | 872.4200 | 2007-12-14 |
| FSM | Tray, Surgical, Instrument | General, Plastic Surgery | Class 1 | 878.4800 | 2021-07-20 |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3011300255 | W&H DENTALWERK BUERMOOS GMBH - SITE 2 | BUERMOOS Salzburg, AT |
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K212910 | Shenzhen Carejoy Technology Co., Ltd. | Dental High-speed Turbine Handpiece, Dental Low-speed Turbine Handpiece | 2022-11-17 |
| K844318 | Pro Pulse, Inc. | ORAL IRRIGATION TIP | 1984-11-23 |
| K905383 | Micro Surgical Instruments Corp. | 2710-000 OSCILLATING SAW, GENERAL ASSEMBLY | 1991-06-18 |
| K913369 | Micro Surgical Instruments Corp. | MICRO-AIRE MODEL 2060 | 1991-11-01 |
| K243921 | Foshan Coxo Medical Instrument Co., Ltd. | LED Curing Lights (DB686 HALO) | 2025-04-11 |
| Recall ID | Recalling Firm | Recall Class | Product Description |
|---|---|---|---|
| Z-0013-2022 | Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel | 1 | Scan Abutment SP, Cat. No. 30-70101 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function. |
| Z-0014-2022 | Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel | 1 | Scan Abutment NP, Cat. No. 30-70102 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function. |
| Z-0015-2022 | Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel | 1 | Scan Abutment MU, Cat. No. 30-70103 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function. |
| Z-0016-2022 | Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel | 1 | Scan Abutment SU, Cat. No. 30-70104 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function. |
| Z-0017-2022 | Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel | 1 | Scan Abutment PCA, Cat. No. 30-70105 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function. |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3017619674 | FOSHAN WENJIAN MEDICAL INSTRUMENT CO., LTD. | Foshan Guangdong, CN |
| 3014471275 | TUNAP GMBH & CO. KG | Wolfratshausen Bavaria, DE |
| 2133714 | INTER-MED, INC. | Racine, WI, US |
| 2246821 | MTI PRECISION PRODUCTS | Coatesville, PA, US |
| 8010468 | GEBR. BRASSELER GMBH & CO. KG | LEMGO North Rhine-Westphalia, DE |
9681479 when referencing this establishment in official correspondence.