# K141886: MDK Handpieces

- Pathway: 510(k) (Traditional)
- Applicant: Modern Korea Co., Ltd.
- Decided: May 13, 2015 after 303 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: 4 generations back to K935676 (1995). 21 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130560: Mastertorque Lux 8900 L, Kaltenbach & Voigt GmbH (2013) Summary page 4.
- K062812: Dental Air-Powered Handpiece, Models Tiger 300T, 300K, 300W, 300B and 300N, Thunder Tiger Corp. (2006) Summary page 4.
- K112305: Vigor a Low Speed Air Motor, Vigor C Low Speed Contra-Angle Handpieces, Vigor S Low Speed Straight Handpieces, Thunder Tiger Corp. (2012) Summary page 4.

## Most influential descendants
- 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
MDK high-speed handpieces are used for the removal of carious material, reducing of hard tooth structure, cavity and crown preparations, removal of fillings, processing and finishing tooth preparations, restorations, and for polishing teeth. MDK low-speed handpieces used for teeth cutting, cavity and crown preparation, restorations and polishing teeth. All the devices are designed for use by a trained professional in the field of general dentistry.

Source page: https://510kreport.com/device/K141886
Methodology: https://510kreport.com/methodology