# K180682: AeroPro Cordless Prophy System

- Pathway: 510(k) (Traditional)
- Applicant: Premier Dental Company Products
- Decided: Feb 27, 2019 after 349 days
- Product code: EKX (Handpiece, Direct Drive, Ac-Powered)
- Device class: 1
- Regulation: 21 CFR 872.4200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
AeroPro™ Cordless Prophy System is a high performance cordless prophylaxis handpiece with a centralized control button for use with disposable prophylaxis angles to perform cleaning and polishing procedures on teeth.

Source page: https://510kreport.com/device/K180682
Methodology: https://510kreport.com/methodology