# K090055: Low & High Speed Kit

- Pathway: 510(k) (Traditional)
- Applicant: Dpm USA Corp.
- Decided: Oct 27, 2009 after 292 days
- Product code: EFA (Handpiece, Belt And/Or Gear Driven, 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
Longest line of descent: 3 generations back to K896877 (1990). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073652: ND Low Speed Airmotor and Handpiece,  Highspeed Airturbine Handpiece, E-Type Straight Nosecone and Contra Angle, Nakamura Magnifier Co., Ltd. (2008) Summary page 1.

## Indications for use
The Elite low speed air motor with Elite "E" contra-angle is to power various attachments which helps the dental clinician perform various dental procedures, removing carious material and excess filling material, cavity and crown preparation,root canal preparations,restorationand polishing teeth. The Medidental high speed handpiece is an air-powereddental handpiece which helps the dental clinician perform various dental procedures such as removing carious materialand excess filling material, cavity and crown preparation,root canal preparations,restoration and polishing teeth.

Source page: https://510kreport.com/device/K090055
Methodology: https://510kreport.com/methodology