# K043498: Twin Power Turbine High Speed Air Turbine Dental Handpiece

- Pathway: 510(k) (Traditional)
- Applicant: J. Morita USA, Inc.
- Decided: Feb 16, 2005 after 61 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
Longest line of descent: 1 generation back to K992011 (1999). 1 ancestor in all.
11 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992011: Synea-HS High Speed-Handpiece, A-Dec, Inc. (1999)

## Most influential descendants
- K061701: High Speed Air Turbine Handpieces, Par-4HEX/4HX Series (Twin Power Turbine 4H) (2006), 7 descendants of its own
- K130560: Mastertorque Lux 8900 L (2013), 5 descendants of its own
- K141886: MDK Handpieces (2015), 3 descendants of its own
- K131319: T1/T2/T3 Turbine Family (2014), 2 descendants of its own
- K203791: Stainless Turbine (2022), 1 descendant of its own

## Indications for use
The TWIN POWER TURBINE handpiece is for use by authorized persons in the practice of dentistry

Source page: https://510kreport.com/device/K043498
Methodology: https://510kreport.com/methodology