FDA Device Registration & Listing · Windsor Ontario, CA · Registration 3007279848
Normalized identity and public registration information from FDA records.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| EFB | Handpiece, Air-Powered, Dental | Dental | Class 1 | 872.4200 | 2024-02-05 |
| MDM | Instrument, Manual, Surgical, General Use | General, Plastic Surgery | Class 1 | 878.4800 | 2024-02-09 |
| EKX | Handpiece, Direct Drive, Ac-Powered | Dental | Class 1 | 872.4200 | 2013-07-05 |
| EBW | Controller, Foot, Handpiece And Cord | Dental | Class 1 | 872.4200 | 2013-07-05 |
| NDP | Accessories, Implant, Dental, Endosseous | Dental | Class 1 | 872.3980 | 2012-12-19 |
| ELC | Scaler, Ultrasonic | Dental | Class 2 | 872.4850 | 2014-11-14 |
| DZI | Drill, Bone, Powered | Dental | Class 2 | 872.4120 | 2014-11-14 |
| EFB | Handpiece, Air-Powered, Dental | Dental | Class 1 | 872.4200 | 2024-02-05 |
| ELC | Scaler, Ultrasonic | Dental | Class 2 | 872.4850 | 2024-02-05 |
| EGS | Handpiece, Contra- And Right-Angle Attachment, Dental | Dental | Class 1 | 872.4200 | 2013-07-05 |
| HAB | Saw, Powered, And Accessories | General, Plastic Surgery | Class 1 | 878.4820 | 2024-02-05 |
| GFA | Blade, Saw, General & Plastic Surgery, Surgical | General, Plastic Surgery | Class 1 | 878.4820 | 2025-09-10 |
| EBW | Controller, Foot, Handpiece And Cord | Dental | Class 1 | 872.4200 | 2013-07-05 |
| EFB | Handpiece, Air-Powered, Dental | Dental | Class 1 | 872.4200 | 2025-03-07 |
| GFF | Bur, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4820 | 2026-06-02 |
| EFB | Handpiece, Air-Powered, Dental | Dental | Class 1 | 872.4200 | 2024-02-08 |
| EFB | Handpiece, Air-Powered, Dental | Dental | Class 1 | 872.4200 | 2024-02-05 |
| EHK | Cup, Prophylaxis | Dental | Class 1 | 872.6290 | 2023-06-13 |
| EFB | Handpiece, Air-Powered, Dental | Dental | Class 1 | 872.4200 | 2023-05-15 |
| KMW | Handpiece, Rotary Bone Cutting | Dental | Class 2 | 872.4120 | 2013-07-05 |
| GEY | Motor, Surgical Instrument, Ac-Powered | General, Plastic Surgery | Class 1 | 878.4820 | 2022-07-05 |
| EFS | Unit, Oral Irrigation | Dental | Class 1 | 872.6510 | 2023-06-13 |
| EBW | Controller, Foot, Handpiece And Cord | Dental | Class 1 | 872.4200 | 2023-05-15 |
| EBW | Controller, Foot, Handpiece And Cord | Dental | Class 1 | 872.4200 | 2013-07-05 |
| EFB | Handpiece, Air-Powered, Dental | Dental | Class 1 | 872.4200 | 2021-06-23 |
| HWE | Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | General, Plastic Surgery | Class 1 | 878.4820 | 2022-07-05 |
| EFB | Handpiece, Air-Powered, Dental | Dental | Class 1 | 872.4200 | 2024-02-05 |
| GBX | Catheter, Irrigation | General, Plastic Surgery | Class 1 | 878.4200 | 2026-05-07 |
| EBW | Controller, Foot, Handpiece And Cord | Dental | Class 1 | 872.4200 | 2024-02-05 |
| EBW | Controller, Foot, Handpiece And Cord | Dental | Class 1 | 872.4200 | 2024-02-05 |
| FLE | Sterilizer, Steam | General Hospital | Class 2 | 880.6880 | 2022-08-30 |
| ELC | Scaler, Ultrasonic | Dental | Class 2 | 872.4850 | 2024-02-08 |
| FSM | Tray, Surgical, Instrument | General, Plastic Surgery | Class 1 | 878.4800 | 2023-06-13 |
| EBW | Controller, Foot, Handpiece And Cord | Dental | Class 1 | 872.4200 | 2013-07-05 |
| 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 |
| K241065 | Dentis Co., Ltd. | ChecQ (AC100) | 2025-03-21 |
| K040153 | Indigenous Peoples Technology and Education Center | I-TEC PORTABLE DENTAL OPERATORY | 2004-05-21 |
| 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 |
| 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 |
3007279848 when referencing this establishment in official correspondence.