Bonart Co., Ltd.: FDA clearances and approvals
Bonart Co., Ltd. has 14 FDA 510(k) clearances (first 2000, latest 2017), across 5 product codes in 1 review panel. Median 510(k) review time: 92 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 1 | 381 |
| 2017 | 1 | 279 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Bonart Co., Ltd.'s cleared 510(k)s took a median 279 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 222 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| ELC | Scaler, Ultrasonic | 7 | 7 |
| EBZ | Activator, Ultraviolet, For Polymerization | 3 | 3 |
| DZI | Drill, Bone, Powered | 2 | 2 |
| EBW | Controller, Foot, Handpiece And Cord | 1 | 1 |
| EGS | Handpiece, Contra- And Right-Angle Attachment, Dental | 1 | 1 |
Review panels
- Dental (14)
Most recent Bonart Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K162856 | Bonart Dental Handpieces (ART), Disposable Prophy Angle (PROFORMANCE) | EGS | 2017-07-18 | 279 |
| K152125 | Oral Surgery System and Accessories | DZI | 2016-08-15 | 381 |
| K100785 | BONART MODEL ART-IM1 IMPLANTOR SYSTEM & ACCESSORIES | EBW | 2010-12-03 | 259 |
| K082971 | BONART ART-L5 LED CORDLESS CURING LIGHT | EBZ | 2008-11-13 | 38 |
| K081550 | BONART ULTRASONIC SCALER, MOEDLS ART-P3II PRO AND ART-MII PRO | ELC | 2008-08-28 | 86 |
| K080761 | BONART'S ARTEOTOMY OMI AND OPI ULTRASONIC SURGERY SYSTEM & ACCESSORIES | DZI | 2008-08-25 | 160 |
| K071981 | BONART MODEL ART-P6 PIEZO ELECTRIC ULTRASONIC SCALER & ACCESSORIES (TIPS) | ELC | 2007-10-26 | 100 |
| K062289 | BONART ART-L3 LED CURING LIGHT | EBZ | 2007-01-03 | 149 |
| K061448 | BONART ART-P3II & P4 PIEZO ELECTRIC ULTRASONIC SCALER UNITS WITH ACCESSORIES | ELC | 2006-08-17 | 87 |
| K052028 | BONART ART-M3II & M4 ULTRASONIC SCALER UNITS WITH ACCESSORIES (INSERTS) | ELC | 2005-10-28 | 93 |
4 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Bonart Co., Ltd..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Bonart Co., Ltd. have?
Bonart Co., Ltd. has 14 FDA 510(k) clearances (first 2000, latest 2017), across 5 product codes in 1 review panel.
How long does FDA take to clear Bonart Co., Ltd.'s 510(k)s?
The median time from FDA receipt to decision across Bonart Co., Ltd.'s cleared 510(k)s is 92 days.
What devices does Bonart Co., Ltd. make?
Its most frequent FDA product codes are ELC (Scaler, Ultrasonic, 7); EBZ (Activator, Ultraviolet, For Polymerization, 3); DZI (Drill, Bone, Powered, 2).
Has Bonart Co., Ltd. had device recalls?
openFDA lists no recalls under a recalling firm name matching Bonart Co., Ltd. Related entities may recall under other names.
Next steps
- See all 14 Bonart Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code ELC, Bonart Co., Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.