# K972642: Perio Control II

- Pathway: 510(k) (Traditional)
- Applicant: Estrad B.V.
- Decided: Jan 26, 1998 after 195 days
- Product code: EIK (Carver, Wax, Dental)
- Device class: 1
- Regulation: 21 CFR 872.4565
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K875076 (1988). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K875076: Florida Probe, Florida Probe Corp. (1988) Summary page 1.

## Indications for use
The Perio Control IT is used during periodontal examination to measure gingival pocket depth. The pocket depth is displayed on the electronics unit and can be entered in an external computer system, either a PC or a Psion Series 3C. Also, the eventual occurrence of bleeding on probing can be registered, as well as the presence of supra-gingival plaque. This is judged visually and registered by pressing one of the buttons on the "Perio Control II"™ handpiece. The pocket depth is measured by entering the probe tip into the gingival pocket and forcing the filament-of the probe up into the sleeve until the sleeve is at a specific reference point. In this position one of the buttons on the "Perio Control II™" handpiece is pressed. The pocket depth is now displayed on the electronics unit. The intended use of the "Perio Control II™" device is to screen.patients and to track disease progression in the target population of patients who are suspected of having or already have periodontal disease. Both pediatric and adult patients may be tested.

Source page: https://510kreport.com/device/K972642
Methodology: https://510kreport.com/methodology