# K032070: Elcacam

- Pathway: 510(k) (Traditional)
- Applicant: A-Dec, Inc.
- Decided: Aug 27, 2003 after 55 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.
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 intraoral camera system, ElcaCam, is used to provide intraoral images of the human mouth and teeth, allowing brilliant, sharp images with larger-than-life pictorial accuracy. It will assist the dentist in examining patient’s teeth to facilitate treatment planning and describing their dental procedures. It will also be used to show a “before” view and an after “view” of the patient’s mouth for visual confirmation of dental procedure results. The ElcaCam is not intended for use as an operative device and is not manufactured to be sterilized.

Source page: https://510kreport.com/device/K032070
Methodology: https://510kreport.com/methodology