BONART ULTRASONIC SCALER, MOEDLS ART-P3II PRO AND ART-MII PRO— 510(k) K081550
Substantially EquivalentBonart Co., Ltd.
FDA 510(k) clearance K081550 for BONART ULTRASONIC SCALER, MOEDLS ART-P3II PRO AND ART-MII PRO, Substantially Equivalent on 2008-08-28. Applicant: Bonart Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Bonart Co., Ltd.
- Product code
- Code ELC
- Device class
- Class 2
- Regulation
- 21 CFR 872.4850
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Walnut, CA, US
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Adverse events under product code ELC
product code ELC- Malfunction
- 1,255
- Total
- 1,255
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.