510(k) K220179
K220179 is an FDA 510(k) premarket notification submitted by Foshan Coxo Medical Instrument Co., Ltd. for the device "High-Speed Air Turbine Handpieces/Straight Handpieces/Geared Angle Handpieces/Air Motors". The FDA issued a decision of Substantially Equivalent on September 22, 2023. The device falls under product code EFB (Handpiece, Air-Powered, Dental), a Class I device regulated under 21 CFR 872.4200. Foshan Coxo Medical Instrument Co., Ltd. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 22, 2023
- Date Received
- January 21, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Handpiece, Air-Powered, Dental
- Device Class
- Class I
- Regulation Number
- 872.4200
- Review Panel
- DE
- Submission Type