# K061701: High Speed Air Turbine Handpieces, Par-4HEX/4HX Series (Twin Power Turbine 4H)

- Pathway: 510(k) (Traditional)
- Applicant: J. Morita USA, Inc.
- Decided: Aug 25, 2006 after 70 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: 2 generations back to K992011 (1999). 2 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043498: Twin Power Turbine High Speed Air Turbine Dental Handpiece, J. Morita USA, Inc. (2005) Summary page 1.

## Most influential descendants
- K130560: Mastertorque Lux 8900 L (2013), 5 descendants of its own
- K141886: MDK Handpieces (2015), 3 descendants of its own
- K262144: DIAMED Handpiece;DIAMED Airmotor;DIAMED Airmotor Handpiece (2026), 0 descendants of its own
- K251388: Dental air-motor handpiece (TM-203B2, TM-203M4, TM-205B2, TM-205M4, TM-IS, TM-ES, TM-SG20, TM-X25, TM-BB, TM-IC, TM-RA41) (2026), 0 descendants of its own
- K202786: Dental Low-speed Handpieces and Accessories (2021), 0 descendants of its own

## Indications for use
The PAR-4HEX/4HX series handpiece is for use by authorized persons in the practice of the dentistry.

Source page: https://510kreport.com/device/K061701
Methodology: https://510kreport.com/methodology