# K040153: I-Tec Portable Dental Operatory

- Pathway: 510(k) (Traditional)
- Applicant: Indigenous Peoples Technology and Education Center
- Decided: May 21, 2004 after 119 days
- Product code: EBW (Controller, Foot, Handpiece And Cord)
- 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 PORTABLE DENTAL HANDPIECE device is a control unit that drives a DC electric micromotor that can be turned on or off by a foot switch. It is intended for use in general dental applications such as cutting a tooth for crown preparation and finishing, cavity preparation, inlay or filling finishing, polishing and endodontic treatment, with use of a contra-angle Doriot Style attachment of equal speed. The micromotor speed is adjustable by the control panel on the top of the control unit from 1,000 to 25,000 rpm.

Source page: https://510kreport.com/device/K040153
Methodology: https://510kreport.com/methodology