# K980106: The Proma Perception, Response and Compass System and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Proma, Inc.
- Decided: Aug 3, 1998 after 203 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
This dental operating unit system is intended for use by professionally trained dentists and their supervised dental hygienists and assistants to support their general, nonsurgical dental diagnostic an restorative procedures performed within contemporary standards of dental patient. When properly used and cared for, the system is safe and effective and meets advertiseyl claims. When equipped with isolated patient water (Bottle) system that is properly installed and cared for, it has been shown to reduce the number of microbes in the water dispensed.

Source page: https://510kreport.com/device/K980106
Methodology: https://510kreport.com/methodology