Data / Medical devices / Taiwan / Bonart Co. Ltd.
Bonart Co. Ltd.: FDA-registered device maker in Keelung, Taiwan, 14 510(k) clearances
Bonart Co. Ltd. is registered with the FDA (registration 9710363) in Keelung, Taiwan. It lists 6 device types. The FDA files 14 510(k) clearances under its listings, the newest dated July 18, 2017. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 9710363
- FEI number
- 3008981576
- Address
- No.80, Wuxun Street Anle District, Keelung, Taiwan, 20446
- Owner or operator
- BONART CO. LTD. (9039893)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- June 22, 2001
- Registered through
- 2027
- Brand names listed
- ART-E1 ELECTROSURGERY UNIT, ART-IM1 IMPLANTOR SYSTEM AND ACCESSORIES, ART-L2 HALOGEN LIGHT CURING UNIT, ART-L3 LED CORDLESS CURING LIGHT, ART-L5 LED CORDLESS CURING LIGHT, ART-M1 MAGNET ULTRASONIC SCALER, ART-M3II MAGNET ULTRASONIC SYSTEM, ART-M4 MAGNET ULTRASONIC SYSTEM and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Activator, Ultraviolet, For Polymerization | EBZ | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Controller, Foot, Handpiece And Cord | EBW | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Drill, Bone, Powered | DZI | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Handpiece, Contra- And Right-Angle Attachment, Dental | EGS | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Scaler, Ultrasonic | ELC | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Unit, Electrosurgical, And Accessories, Dental | EKZ | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 18, 2017 | K162856 | Bonart Dental Handpieces (ART), Disposable Prophy Angle (PROFORMANCE) | EGS | Substantially Equivalent | Bonart Co., Ltd. | accessdata.fda.gov |
| August 15, 2016 | K152125 | Oral Surgery System and Accessories | DZI | Substantially Equivalent | Bonart Co., Ltd. | accessdata.fda.gov |
| December 3, 2010 | K100785 | BONART MODEL ART-IM1 IMPLANTOR SYSTEM & ACCESSORIES | EBW | Substantially Equivalent | Bonart Co., Ltd. | accessdata.fda.gov |
| November 13, 2008 | K082971 | BONART ART-L5 LED CORDLESS CURING LIGHT | EBZ | Substantially Equivalent | Bonart Co., Ltd. | accessdata.fda.gov |
| August 28, 2008 | K081550 | BONART ULTRASONIC SCALER, MOEDLS ART-P3II PRO AND ART-MII PRO | ELC | Substantially Equivalent | Bonart Co., Ltd. | accessdata.fda.gov |
| August 25, 2008 | K080761 | BONART'S ARTEOTOMY OMI AND OPI ULTRASONIC SURGERY SYSTEM & ACCESSORIES | DZI | Substantially Equivalent | Bonart Co., Ltd. | accessdata.fda.gov |
| October 26, 2007 | K071981 | BONART MODEL ART-P6 PIEZO ELECTRIC ULTRASONIC SCALER & ACCESSORIES (TIPS) | ELC | Substantially Equivalent | Bonart Co., Ltd. | accessdata.fda.gov |
| January 3, 2007 | K062289 | BONART ART-L3 LED CURING LIGHT | EBZ | Substantially Equivalent | Bonart Co., Ltd. | accessdata.fda.gov |
| August 17, 2006 | K061448 | BONART ART-P3II & P4 PIEZO ELECTRIC ULTRASONIC SCALER UNITS WITH ACCESSORIES | ELC | Substantially Equivalent | Bonart Co., Ltd. | accessdata.fda.gov |
| October 28, 2005 | K052028 | BONART ART-M3II & M4 ULTRASONIC SCALER UNITS WITH ACCESSORIES (INSERTS) | ELC | Substantially Equivalent | Bonart Co., Ltd. | accessdata.fda.gov |
| January 10, 2003 | K023721 | BONART ART-L2 LIGHT CURING UNIT | EBZ | Substantially Equivalent | Bonart Co., Ltd. | accessdata.fda.gov |
| February 19, 2002 | K020080 | BONART ART-E1 ELECTROSURGERY UNIT | EKZ | Substantially Equivalent | Diagnostic Data, Inc. | accessdata.fda.gov |
| May 15, 2000 | K000510 | ART-M1, MODEL M1-1-ART-A1 | ELC | Substantially Equivalent | Bonart Co., Ltd. | accessdata.fda.gov |
| March 6, 2000 | K994299 | ART-P3, MODEL P3-1-ART-A1 | ELC | Substantially Equivalent | Bonart Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Drill, Bone, Powered
- All makers of Scaler, Ultrasonic
- All makers of Unit, Electrosurgical, And Accessories, Dental
- All makers of Handpiece, Contra- And Right-Angle Attachment, Dental
- All makers of Activator, Ultraviolet, For Polymerization
- All makers of Controller, Foot, Handpiece And Cord
Updated July 18, 2017. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.