BONART'S ARTEOTOMY OMI AND OPI ULTRASONIC SURGERY SYSTEM & ACCESSORIES— 510(k) K080761
Substantially EquivalentBonart Co., Ltd.
FDA 510(k) clearance K080761 for BONART'S ARTEOTOMY OMI AND OPI ULTRASONIC SURGERY SYSTEM & ACCESSORIES, Substantially Equivalent on 2008-08-25. Applicant: Bonart Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Bonart Co., Ltd.
- Product code
- Code DZI
- Device class
- Class 2
- Regulation
- 21 CFR 872.4120
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Walnut, CA, US
Recent devices under product code DZI
view allMore clearances from Bonart Co., Ltd.
view all- K162856 — Bonart Dental Handpieces (ART), Disposable Prophy Angle (PROFORMANCE)
- K152125 — Oral Surgery System and Accessories
- K100785 — BONART MODEL ART-IM1 IMPLANTOR SYSTEM & ACCESSORIES
- K082971 — BONART ART-L5 LED CORDLESS CURING LIGHT
- K081550 — BONART ULTRASONIC SCALER, MOEDLS ART-P3II PRO AND ART-MII PRO
Data sourced from openFDA. This site is unofficial and independent of the FDA.