510(k) K180682
K180682 is an FDA 510(k) premarket notification submitted by Premier Dental Company Products for the device "AeroPro Cordless Prophy System". The FDA issued a decision of Substantially Equivalent on February 27, 2019. The device falls under product code EKX (Handpiece, Direct Drive, Ac-Powered), a Class I device regulated under 21 CFR 872.4200. Premier Dental Company Products has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 27, 2019
- Date Received
- March 15, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Handpiece, Direct Drive, Ac-Powered
- Device Class
- Class I
- Regulation Number
- 872.4200
- Review Panel
- DE
- Submission Type