High-Speed Air Turbine Handpieces/Straight Handpieces/Geared Angle Handpieces/Air Motors— 510(k) K220179
Substantially EquivalentFoshan Coxo Medical Instrument Co., Ltd.
FDA 510(k) clearance K220179 for High-Speed Air Turbine Handpieces/Straight Handpieces/Geared Angle Handpieces/Air Motors, Substantially Equivalent on 2023-09-22. Applicant: Foshan Coxo Medical Instrument Co., Ltd.. Device class: 1.
Clearance details
- Applicant
- Foshan Coxo Medical Instrument Co., Ltd.
- Product code
- Product code EFB
- Device class
- Class 1
- Regulation
- 21 CFR 872.4200
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Foshan, CN
Recent devices under product code EFB
view all- K260029 — Firstar Dental Handpieces
- K262144 — DIAMED Handpiece; DIAMED Airmotor; DIAMED Airmotor Handpiece
- K251388 — Dental air-motor handpiece (TM-203B2, TM-203M4, TM-205B2, TM-205M4, TM-IS, TM-ES, TM-SG20, TM-X25, TM-BB, TM-IC, TM-RA41)
- K251389 — High speed air turbine handpiece
- K242179 — Synea Fusion Handpieces (Intensiv & Profin)
More clearances from Foshan Coxo Medical Instrument Co., Ltd.
view allAdverse events under product code EFB
product code EFB- Injury
- 133
- Malfunction
- 562
- Total
- 695
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.