510(k) K172164
K172164 is an FDA 510(k) premarket notification submitted by Propel Orthodontics, LLC for the device "PROPEL Device". The FDA issued a decision of Substantially Equivalent on January 17, 2018. The device falls under product code DZJ (Driver, Wire, And Bone Drill, Manual), a Class II device regulated under 21 CFR 872.4120. Propel Orthodontics, LLC has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 17, 2018
- Date Received
- July 18, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Driver, Wire, And Bone Drill, Manual
- Device Class
- Class II
- Regulation Number
- 872.4120
- Review Panel
- DE
- Submission Type