Manufacturer registered with FDA
Bonart Co., Ltd.
KEELUNG, Taiwan. Lists 6 dental device types with FDA across 1 registered establishment, and holds 14 510(k) clearances as applicant.
- Device types listed
- 6
- Brands and models
- 15
- 510(k) clearances
- 142000–2017
- Markets registered in
- 525 registrations outside the US
- Establishments
- 1Taiwan
510(k) clearances per year, 2000–2026
Registered in 5 markets
Where regulators' registries name Bonart Co., Ltd. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Bonart Co., Ltd. | 14 clearances | 2000–2017 | Below |
| Costa Rica | Ministerio de Salud | Manufacturer | BONART CO. LTDBONART CO. LTD. | 11 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | BONART CO.LTDBonart Co., Ltd. · BONART CO., LTD · +2 | 7 | 2000–2013 | Pure Global AI |
| Israel | AMAR | Manufacturer | Bonart CO. LTD.Bonart Co.,Ltd. · Bonart Co., Ltd. | 5 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Bonart Co Ltd | 2 | 2011–2018 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Bonart Co., Ltd. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Ultrasonic ScalerELC · Class 2 | Ultrasonic scalers | Maker | ART-M1 MAGNET ULTRASONIC SCALERART-M3II MAGNET ULTRASONIC SYSTEMART-M4 MAGNET ULTRASONIC SYSTEMART-P3 PIEZO ELECTRIC SCALERART-P3II / M3II PRO MULTI FUNCTIONART-P3II/P4 PIEZOELECTRIC SCALERART-P6 PIEZOELECTRIC SCALER | 2001 |
| Ultraviolet Activator for PolymerizationEBZ · Class 2 | Curing lights | Maker | ART-L2 HALOGEN LIGHT CURING UNITART-L3 LED CORDLESS CURING LIGHTART-L5 LED CORDLESS CURING LIGHT | 2007 |
| Powered Bone DrillDZI · Class 2 | Surgical drills & motors | Maker | ARTEOTOMY Oral Surgery System and Accessories (Model No. BIS)ARTEOTOMY-OM1/OP1 ULT.SURGERY SYS. | 2008 |
| Handpiece and Cord Foot ControllerEBW · Class 1 | — | Maker | ART-IM1 IMPLANTOR SYSTEM AND ACCESSORIES | 2010 |
| Dental Contra- and Right-Angle Attachment HandpieceEGS · Class 1 | Dental handpieces | Maker | Bonart (ART) Dental Handpieces, Disposable Prophy Angle (PROFORMANCE) & Accessories | 2017 |
| Dental Electrosurgical Unit and AccessoriesEKZ · Class 2 | — | Maker | ART-E1 ELECTROSURGERY UNIT | 2007 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Bonart Co., Ltd. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 18 Jul 2017 | K162856 | Bonart Dental Handpieces (ART), Disposable Prophy Angle (PROFORMANCE) | EGS Dental Contra- and Right-Angle Attachment Handpiece |
| 15 Aug 2016 | K152125 | Oral Surgery System and Accessories | DZI Powered Bone Drill |
| 3 Dec 2010 | K100785 | BONART MODEL ART-IM1 IMPLANTOR SYSTEM & ACCESSORIES | EBW Handpiece and Cord Foot Controller |
| 13 Nov 2008 | K082971 | BONART ART-L5 LED CORDLESS CURING LIGHT | EBZ Ultraviolet Activator for Polymerization |
| 28 Aug 2008 | K081550 | BONART ULTRASONIC SCALER, MOEDLS ART-P3II PRO AND ART-MII PRO | ELC Ultrasonic Scaler |
| 25 Aug 2008 | K080761 | BONART'S ARTEOTOMY OMI AND OPI ULTRASONIC SURGERY SYSTEM & ACCESSORIES | DZI Powered Bone Drill |
| 26 Oct 2007 | K071981 | BONART MODEL ART-P6 PIEZO ELECTRIC ULTRASONIC SCALER & ACCESSORIES (TIPS) | ELC Ultrasonic Scaler |
| 3 Jan 2007 | K062289 | BONART ART-L3 LED CURING LIGHT | EBZ Ultraviolet Activator for Polymerization |
| 17 Aug 2006 | K061448 | BONART ART-P3II & P4 PIEZO ELECTRIC ULTRASONIC SCALER UNITS WITH ACCESSORIES | ELC Ultrasonic Scaler |
| 28 Oct 2005 | K052028 | BONART ART-M3II & M4 ULTRASONIC SCALER UNITS WITH ACCESSORIES (INSERTS) | ELC Ultrasonic Scaler |
| 10 Jan 2003 | K023721 | BONART ART-L2 LIGHT CURING UNIT | EBZ Ultraviolet Activator for Polymerization |
| 15 May 2000 | K000510 | ART-M1, MODEL M1-1-ART-A1 | ELC Ultrasonic Scaler |
| 6 Mar 2000 | K994299 | ART-P3, MODEL P3-1-ART-A1 | ELC Ultrasonic Scaler |
| 6 Mar 2000 | K994203 | ART-M3 25K, MODEL M3-1-ART2-A1; ART-M3 30K, MODEL M3-1-ART3-A1 | ELC Ultrasonic Scaler |
Also lists devices cleared under other names
Bonart Co., Ltd. lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Diagnostic Data, Inc. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 19 Feb 2002 | K020080 | BONART ART-E1 ELECTROSURGERY UNIT | Diagnostic Data, Inc. | EKZ Dental Electrosurgical Unit and Accessories |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| BONART CO. LTD.FDA reg. 9710363 | KEELUNG, Taiwan | Contract manufacturer, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9039893). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.