Bonart Co. Ltd.
Keelung, TW
BONART CO. LTD. appears in FDA device records in Keelung, TW. FDA records list 14 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 14 510(k) clearances for Bonart Co. Ltd. between 2000 and 2017. The busiest year on record is 2000, with 3. The most recent is 2017, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2000 | 3 |
| 2003 | 1 |
| 2005 | 1 |
| 2006 | 1 |
| 2007 | 2 |
| 2008 | 3 |
| 2010 | 1 |
| 2016 | 1 |
| 2017 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K162856 | Bonart Dental Handpieces (ART), Disposable Prophy Angle (PROFORMANCE) | EGS | Substantially Equivalent | |
| K152125 | Oral Surgery System and Accessories | DZI | Substantially Equivalent | |
| K100785 | BONART MODEL ART-IM1 IMPLANTOR SYSTEM & ACCESSORIES | EBW | Substantially Equivalent | |
| K082971 | BONART ART-L5 LED CORDLESS CURING LIGHT | EBZ | Substantially Equivalent | |
| K081550 | BONART ULTRASONIC SCALER, MOEDLS ART-P3II PRO AND ART-MII PRO | ELC | Substantially Equivalent | |
| K080761 | BONART'S ARTEOTOMY OMI AND OPI ULTRASONIC SURGERY SYSTEM & ACCESSORIES | DZI | Substantially Equivalent | |
| K071981 | BONART MODEL ART-P6 PIEZO ELECTRIC ULTRASONIC SCALER & ACCESSORIES (TIPS) | ELC | Substantially Equivalent | |
| K062289 | BONART ART-L3 LED CURING LIGHT | EBZ | Substantially Equivalent | |
| K061448 | BONART ART-P3II & P4 PIEZO ELECTRIC ULTRASONIC SCALER UNITS WITH ACCESSORIES | ELC | Substantially Equivalent | |
| K052028 | BONART ART-M3II & M4 ULTRASONIC SCALER UNITS WITH ACCESSORIES (INSERTS) | ELC | Substantially Equivalent | |
| K023721 | BONART ART-L2 LIGHT CURING UNIT | EBZ | Substantially Equivalent | |
| K000510 | ART-M1, MODEL M1-1-ART-A1 | ELC | Substantially Equivalent | |
| K994299 | ART-P3, MODEL P3-1-ART-A1 | ELC | Substantially Equivalent | |
| K994203 | ART-M3 25K, MODEL M3-1-ART2-A1; ART-M3 30K, MODEL M3-1-ART3-A1 | ELC | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 9710363 | 3008981576 | BONART CO. LTD. | NO.80, WUXUN STREET, KEELUNG 20446 TW | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain