# K974542: True Vision, True Vision II

- Pathway: 510(k) (Traditional)
- Applicant: Medical Dynamics, Inc.
- Decided: Feb 17, 1998 after 76 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
These intra-oral Dental Cameras are for use in dentistry to be able to show the patient abnormalities and pathology within the mouth. The cameras are utilized exclusively to inform the patient of conditions in the mouth which require treatment. It is not intended that the dental intra-oral camera be utilized in any dental operative procedure. The camera is ptovidedlm-m and the camera is not built so that it can tolerate any sterilization process. The camera system does provide a "clean", optically clear covering for the distal end of the handpiece. This provides a "clean" covering for the distal handpiece, and is intended for one time use only.

Source page: https://510kreport.com/device/K974542
Methodology: https://510kreport.com/methodology