Bonart Dental Handpieces (ART), Disposable Prophy Angle (PROFORMANCE)— 510(k) K162856
Substantially EquivalentBonart Co., Ltd.
FDA 510(k) clearance K162856 for Bonart Dental Handpieces (ART), Disposable Prophy Angle (PROFORMANCE), Substantially Equivalent on 2017-07-18. Applicant: Bonart Co., Ltd.. Device class: 1.
Clearance details
- Applicant
- Bonart Co., Ltd.
- Product code
- Code EGS
- Device class
- Class 1
- Regulation
- 21 CFR 872.4200
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Keelung City, TW
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Adverse events under product code EGS
product code EGS- Injury
- 356
- Malfunction
- 759
- Total
- 1,115
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.