# K982105: Oral Potential Meter (Opm)

- Pathway: 510(k) (Traditional)
- Applicant: Pertec of Wisconsin, Inc.
- Decided: Sep 16, 1998 after 92 days
- Product code: LFC (Device, Caries Detection)
- Device class: 2
- Regulation: 21 CFR 872.1740
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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.

## Most influential descendants
- K170822: Electronic Caries Detector (2017), 0 descendants of its own

## Indications for use
Caries detection Device The Oral Potential Meter aids the dental professional in detecting potential caries. Meaurements above 10 millivolts, 1 microamp and 0.01 microwatts x seconds indicates a need for the dental professional to look at potentially carious leasions by also using other means, such as direct exploration, radiographs, etc. The OPM aids in determing potentially active caries and can not detect mineralized caries that have no potenial energy. Remineralized teeth are no longer considered carious. The OPM is a device that measures and displays voltage and conducts through caries related to metallic restorations in the oral cavity. The dentist may be able to, on visual exam, detect caries at the margins or with x-ray- under a restoration with these readings. It also provides a power measurement (energy or joules) integrated over a measured period of time and displays it. The meter has two probes that are used to make the measurements. One is a reference probe, Red, with push-button switch to turn on the meter and initiate the ineasurements. The other is used as the primary input, Black to the meter’s electronics

Source page: https://510kreport.com/device/K982105
Methodology: https://510kreport.com/methodology