# K113301: Concenpiece,High-Speed Handpiece Series

- Pathway: 510(k) (Traditional)
- Applicant: Dentalez, Inc.
- Decided: Jan 23, 2012 after 76 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 K960719 (1996). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960719: Star Dental 430 Series High Speed Handpiece, Dentalez Group (1996) Summary page 1.

## Most influential descendants
- K173465: Concentrix MX-AC High-Speed Handpiece (2018), 0 descendants of its own

## Indications for use
The Concentrix High-Speed Handpieces are used by trained dental professionals for a variety of procedures including but not limited to caries and amalgam removal, restorative work and crown preparations.

Source page: https://510kreport.com/device/K113301
Methodology: https://510kreport.com/methodology