PROPEL Device
by Propel Orthodontics LLC 2 variants
510(k) K172164
PROPEL Device is a medical device (FDA Class II; FDA product code DZJ, Driver, Wire, And Bone Drill, Manual) made by Propel Orthodontics LLC, cleared under FDA 510(k) K172164 on 17 Jan 2018, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK172164 | Date17 Jan 2018 | StatusActive |
Official records
- FDA 510(k) database K172164
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- DZJ
- FDA applicant
- Propel Orthodontics, LLC
- Device class
- Class II
- Regulation
- 21 CFR Part 872.4120
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
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