# K111541: Endo-Express (R) Handpiece

- Pathway: 510(k) (Traditional)
- Applicant: Essential Dental Systems, Inc.
- Decided: Mar 16, 2012 after 288 days
- Product code: EGS (Handpiece, Contra- And Right-Angle Attachment, 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 K962540 (1996). 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)
- K962540: E-Type Contra Angle Nac-E, Nsk Nakanishi, Inc. (1996) Summary page 1.

## Indications for use
Endo-Express® Handpiece is indicated for the removal of dentin, shaping and obturation of the root canal. This application area extends to endodontic procedures using NITI or stainless steel endodontic instruments intended by the manufacturer for use in. the mechanical preparation of root canals.

Source page: https://510kreport.com/device/K111541
Methodology: https://510kreport.com/methodology