# K113222: ND Lowspeed Airmotor,ND Highspeed Airturbine Handpiece

- Pathway: 510(k) (Traditional)
- Applicant: Nakamura Dental Handpiece Mfg. Co., Ltd.
- Decided: Feb 23, 2012 after 114 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
ND Iowspeed airmotor, MP-50M, is used to power prophy angle attachment that helps dental clinician perform the hygiene dentistry work such as cleaning. The device is autoclavable. ND low speed airmotor, MS-1GOM / MS-55M, are used to power attachment that helps dental clinician perform various dental work such as cleaning, tooth carving, others. The device is autoclavable. ND star-type straight nosecone attachment, STS-30H, is powered by either Iowspeed airmotor or electric micromotor for removing carious material and excess filling material, cavity and crown preparation, root canal preparations, finishing tooth preparations, restorations and polishing teeth. The device is autoclavable. ND star-type contra angle attachment, STC-20L / STU-20ML / STU-35BL / STU-3OBLP, are powered by either Iowspeed airmotor or electric micromotor for removing carlous material and excess filling material, cavity and crown preparation, root canal preparations, finishing tooth preparations, restorations and polishing teeth. The device is autoclavable ND highspeed airturbine handpiece. TCP-700M I TCP-7008 / TC-80QM / TC-BOQB, are air-powered dental handpiece for removing carious material and excess filling material, cavity and crown preparation, root canal preparations, finishing tooth preparations, restoration and polishing teet The device is autoclavable.

Source page: https://510kreport.com/device/K113222
Methodology: https://510kreport.com/methodology