# K973410: Ultracam

- Pathway: 510(k) (Traditional)
- Applicant: W. Edward Johansen
- Decided: Oct 8, 1998 after 394 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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.

## Most influential descendants
- K013690: Ident-A100 Intraoral Video Camera (2002), 0 descendants of its own

## Indications for use
The intraoral camera system, Ultracam, of Dental Vision Direct, Inc. is ueed to provide a view of the mouth in order to assist the dentist in describing dental procedures and to show a patient before and after views of his mouth showing the patient results of the dental procedures which the dentist has performed on him.

Source page: https://510kreport.com/device/K973410
Methodology: https://510kreport.com/methodology