510(k) K192409
K192409 is an FDA 510(k) premarket notification submitted by Dentsply Sirona for the device "Midwest Rhino XE and Air Motor M". The FDA issued a decision of Substantially Equivalent on Jan 13, 2020. The device falls under product code EFB (Handpiece, Air-Powered, Dental), a Class I device regulated under 21 CFR 872.4200. Dentsply Sirona has 87 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 13, 2020
- Date Received
- Sep 4, 2019
- 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
- 510(k)