# K040117: Uniport Self-Contained Portable Dental Unit

- Pathway: 510(k) (Traditional)
- Applicant: Arrow Industries, LLC
- Decided: Apr 21, 2004 after 92 days
- Product code: EIA (Unit, Operative Dental)
- Device class: 1
- Regulation: 21 CFR 872.6640
- 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 K903451 (1990). 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)
- K903451: A-Dec Pac I Portable Unit, A-Dec, Inc. (1990) Summary page 1.

## Indications for use
This device is intended for delivery of general restorative dental care for those who cannot visit the dental office.

Source page: https://510kreport.com/device/K040117
Methodology: https://510kreport.com/methodology