510(k) · Cleared
ClearedPerio Protect Tray
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Perio Protect, LLC · KMT Tray, Fluoride, Disposable
Cleared on Jan 23, 2004 as substantially equivalent to K811154 (Hoyt Laboratories, 1981) after a 225-day review. Its family tree reaches back 1 generation to 1981.
- Decided
- Jan 23, 2004
- Review
- 225 days
- Class
- Class I
- Product code
- KMT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K811154 (1981). No later device cites it as a predicate yet.
- Root · 1 generation backK811154 Hoyt Econo-TrayHoyt Laboratories · 1981
- This deviceK031809 Perio Protect TrayPerio Protect, LLC · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K811154 | Hoyt Econo-Tray | Hoyt Laboratories | 1981 | — |
| 0 (this device) | K031809 | Perio Protect Tray | Perio Protect, LLC | 2004 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KMT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K811154 | Hoyt Econo-TraySummary page 2…in place are a part of the practice of dentistry, and are to be determined by the clinician. 5. PREDICATE DEVICE Hoyt Laboratories Disposable Fluoride Tray - K 811154 Such products are now Class I Exempt per 21 C.F.R § 872.6870 (2002) Sub… | 1981 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
How does its category compare?
All KMT devicesKMT Tray, Fluoride, Disposable: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KMT
FDA has decided no KMT device since 2007.
Median 510(k) review, days · KMT
Too few KMT 510(k)s in any year since 2007 to give a median.
Recalls per year · KMT
No recall names KMT since 2007.
Adverse event reports per year · KMT
1in 2014
MAUDE reports naming product code KMT, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031809 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031809: Perio Protect Tray.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031809
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026