# K040116: Hawk Intraoral Camera and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Dxm Co., Ltd.
- Decided: Apr 20, 2004 after 91 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 K021083 (2002). 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)
- K021083: Veracam, Lumalite, Inc. (2002) Summary page 1.

## Indications for use
The Hawk Intraoral Camera and Accessories are indicated for use to provide a view of mouth to assist the dentist in describing dental procedures and to show the patient the mouth before and after dental procedures.

Source page: https://510kreport.com/device/K040116
Methodology: https://510kreport.com/methodology