# K992380: Endo-Eze Motor and Handpiece

- Pathway: 510(k) (Traditional)
- Applicant: Ultradent Products, Inc.
- Decided: Oct 13, 1999 after 89 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Endo-Eze 965A UL Contra-Angle Handpiece is designed to be used with the Endo-Eze Shaping Files and all other files with handle diameters up to 2.35 mm. The Endo-Eze A25 UL Air Motor and Handpiece is a mechanical device to be used by dentists performing root canal treatment.

Source page: https://510kreport.com/device/K992380
Methodology: https://510kreport.com/methodology