# K202674: Medidenta High Speed Handpieces

- Pathway: 510(k) (Traditional)
- Applicant: Pac-Dent, Inc.
- Decided: Dec 12, 2022 after 818 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
Medidenta High Speed Handpieces are intended for removing carious material, cavities and crown preparations, removal of fillings, and processing of tooth and restoration surfaces. They are designed for use by a trained professional in the field of general dentistry.

Source page: https://510kreport.com/device/K202674
Methodology: https://510kreport.com/methodology