# K181900: Dental high speed handpiece, Dental low speed handpiece

- Pathway: 510(k) (Traditional)
- Applicant: Foshan Cicada Dental Instrument Co, Ltd.
- Decided: Dec 9, 2019 after 511 days
- Product code: EFB (Handpiece, Air-Powered, Dental)
- 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
Dental high speed handpiece: Is intended for removing carious material, reducing hard tooth structure, cavity and crown preparations, removal of fillings, finishing tooth preparations, restoration and polishing teeth. The device is designed for use by a trained professional in the field of general dentistry. Dental low speed handpiece: Is intended for preparing dental cavities and crown for restorations, and teeth cutting, restorations and polishing teeth. The device is designed for use by a trained professional in the field of general dentistry.

Source page: https://510kreport.com/device/K181900
Methodology: https://510kreport.com/methodology