# K101551: Pacemaker High-Speed Handpiece Model PM-MQ, PM-M

- Pathway: 510(k) (Traditional)
- Applicant: Delma Medical Instrument (Guangzhou) Co., Ltd.
- Decided: Sep 9, 2010 after 97 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: 5 generations back to K935676 (1995). 10 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052822: Dental Air-Powered Handpiece, Models Tiger 100, 101, 200, 201 and 202, Thunder Tiger Corp. (2006) Summary page 1.
- K062812: Dental Air-Powered Handpiece, Models Tiger 300T, 300K, 300W, 300B and 300N, Thunder Tiger Corp. (2006) Summary page 1.
- K062740: Jindell High Spped Air Turbine Handpiece, Models SW, SP, SU, Etu, MU, Jindell Medical Instruments Co., Ltd. (2006) Summary page 2.
- K093084: Rolence Dental High Speed Handpiece, RHP, Rolence Ent., Inc. (2009) Summary page 2.
- K063110: CST61 High Speed Turbine Handpiece, Shanghai Dental Instrument Factory (2006) Summary page 2.
- K021250: MK-Dent Push Button Highspeed Handpiece, 4 Holes, Models HS 2012 (Standard Head) & HS 2014 (Small Head), Handpiece Unlimited (2002) Summary page 2.

## Most influential descendants
- K112623: Airlight Dental Handpiece (2011), 0 descendants of its own

## Indications for use
PACEMAKER High-Speed Handpiece, models PM-MQ and PM-M are intended for removing carious material, reducing hard tooth structure, cavity prepardtion, finishing tooth preparations and restorations and polishing teeth.

Source page: https://510kreport.com/device/K101551
Methodology: https://510kreport.com/methodology