Company ยท US
Bonart Co., Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 2000 to 2017. Name variants (Inc, Corp, punctuation) are merged.
14510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 18, 2017 | K162856 | Bonart Dental Handpieces (ART), Disposable Prophy Angle (PROFORMANCE) Bonart Co., Ltd., TW | EGS |
| Aug 15, 2016 | K152125 | Oral Surgery System and Accessories Bonart Co., Ltd., TW | DZI |
| Dec 3, 2010 | K100785 | BONART MODEL ART-IM1 IMPLANTOR SYSTEM & ACCESSORIES Bonart Co., Ltd. | EBW |
| Nov 13, 2008 | K082971 | BONART ART-L5 LED CORDLESS CURING LIGHT Bonart Co., Ltd. | EBZ |
| Aug 28, 2008 | K081550 | BONART ULTRASONIC SCALER, MOEDLS ART-P3II PRO AND ART-MII PRO Bonart Co., Ltd. | ELC |
| Aug 25, 2008 | K080761 | BONART'S ARTEOTOMY OMI AND OPI ULTRASONIC SURGERY SYSTEM & ACCESSORIES Bonart Co., Ltd. | DZI |
| Oct 26, 2007 | K071981 | BONART MODEL ART-P6 PIEZO ELECTRIC ULTRASONIC SCALER & ACCESSORIES (TIPS) Bonart Co., Ltd. | ELC |
| Jan 3, 2007 | K062289 | BONART ART-L3 LED CURING LIGHT Bonart Co., Ltd. | EBZ |
| Aug 17, 2006 | K061448 | BONART ART-P3II & P4 PIEZO ELECTRIC ULTRASONIC SCALER UNITS WITH ACCESSORIES Bonart Co., Ltd. | ELC |
| Oct 28, 2005 | K052028 | BONART ART-M3II & M4 ULTRASONIC SCALER UNITS WITH ACCESSORIES (INSERTS) Bonart Co., Ltd. | ELC |
| Jan 10, 2003 | K023721 | BONART ART-L2 LIGHT CURING UNIT Bonart Co., Ltd. | EBZ |
| May 15, 2000 | K000510 | ART-M1, MODEL M1-1-ART-A1 Bonart Co., Ltd., TW | ELC |
| Mar 6, 2000 | K994299 | ART-P3, MODEL P3-1-ART-A1 Bonart Co., Ltd., TW | ELC |
| Mar 6, 2000 | K994203 | ART-M3 25K, MODEL M3-1-ART2-A1; ART-M3 30K, MODEL M3-1-ART3-A1 Bonart Co., Ltd., TW | ELC |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||