# K031809: Perio Protect Tray

- Pathway: 510(k) (Traditional)
- Applicant: Perio Protect, LLC
- Decided: Jan 23, 2004 after 225 days
- Product code: KMT (Tray, Fluoride, Disposable)
- Device class: 1
- Regulation: 21 CFR 872.6870
- 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 K811154 (1981). 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)
- K811154: Hoyt Econo-Tray, Hoyt Laboratories (1981) Summary page 2.

## Indications for use
The Perio Protect Tray is intended to be used to place solutions of the clinician's choice into gingival crevices or periodontal pockets. The design of the Perio Protect Tray permits placement of solutions deeper into the crevice/pocket than is possible with traditional fluoride trays. The choice of solution, the frequency of use, and the time the tray is to be in place are a part of the practice of dentistry, and are to be determined by the clinician.

Source page: https://510kreport.com/device/K031809
Methodology: https://510kreport.com/methodology