# K020957: Oracam

- Pathway: 510(k) (Traditional)
- Applicant: Video Dental Concepts, Inc.
- Decided: Jun 13, 2002 after 80 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.
- (no number) Stomavision: named in the summary without a submission number
- (no number) Vipercam: named in the summary without a submission number
- (no number) Telicam: named in the summary without a submission number
- (no number) Digital Doc: named in the summary without a submission number
- (no number) S555: named in the summary without a submission number
- (no number) S575: named in the summary without a submission number
- (no number) MiniCam: named in the summary without a submission number
- (no number) Smilie PC systems: named in the summary without a submission number

## Indications for use
The OraCam is used to provide Intra oral images of the human mouth and teeth, allowing brilliant, sharp images with larger-than-life pictorial accuracy allowing the dentist to examine patient’s teeth in order for them to adequately plan in the treatment. The OraCam is therefore similar in indicated use as Stomavision, Vipercam, Telicam, Digital Doc, S555 and S575, MiniCam and Smilie PC systems, in its intended use.

Source page: https://510kreport.com/device/K020957
Methodology: https://510kreport.com/methodology