# K972033: Planmeca Intracam

- Pathway: 510(k) (Traditional)
- Applicant: Planmeca Oy
- Decided: Jun 20, 1997 after 18 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 Planmeca IntraCam intra oral video camera is a dental operative unit accessory, which is intended for use by practitioners in the dental field for use as an aid or adjunct to assist in viewing intra oral anatomies and capturing and storing images for later retrieval. The camera interfaces with video printers, TV/monitors, capture boards etc., and is designed to be located as an instrument in a dental unit.

Source page: https://510kreport.com/device/K972033
Methodology: https://510kreport.com/methodology