# K070001: Master Classic 5K Low Speed Handpiece, 20K Low Speed Handpiece, TM5 Low Speed Handpiece and TM20 Low Speed Handpiece

- Pathway: 510(k) (Special)
- Applicant: Mti Precision Products
- Decided: Feb 2, 2007 after 30 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 K940261 (1994). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K940261: Lynx Low-Speed Handpiece, Mti Precision Products (1994) Summary page 1.

## Indications for use
The Lube Free Low Speed Handpiece line comprises a family of air driven low speed dental motors, FDA classification code EFB, for use in dental non-surgical operatory and laboratory procedures by licensed practitioners. The dental motors are known as: Master Classic 5K Low Speed Handpiece Master Classic 20K Low Speed Handpiece Master TM5 5K Low Speed Handpiece Master TM20 20K Low Speed Handpiece The following are examples for which the motors can be utilized. Note that these are just examples and not limitations of the procedures for which the handpieces can be used. * Grinding and trimming on dentures and bridge work. * Polishing and finishing of natural dentition * Endodontic access procedures * Cavity preparation * Crown and cap preparation * Post and pin setting * Implant setting The handpieces utilize materials known for their ability to withstand many exposures to common cleaning and disinfecting agents and steam sterilization.

Source page: https://510kreport.com/device/K070001
Methodology: https://510kreport.com/methodology