510(k) K181900
K181900 is an FDA 510(k) premarket notification submitted by Foshan Cicada Dental Instrument Co, Ltd. for the device "Dental high speed handpiece, Dental low speed handpiece". The FDA issued a decision of Substantially Equivalent on December 9, 2019. The device falls under product code EFB (Handpiece, Air-Powered, Dental), a Class I device regulated under 21 CFR 872.4200. Foshan Cicada Dental Instrument Co, Ltd. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 9, 2019
- Date Received
- July 16, 2018
- 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