Cleared Traditional

PERIO PROTECT TRAY (K031809) - FDA 510(k) Clearance

Class I Dental device.

K031809 · Perio Protect, LLC · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2004
Decision
225d
Days
Class 1
Risk

K031809 is an FDA 510(k) clearance for the PERIO PROTECT TRAY. Classified as Tray, Fluoride, Disposable (product code KMT), Class I - General Controls.

Submitted by Perio Protect, LLC (Washington, US). The FDA issued a Cleared decision on January 23, 2004 after a review of 225 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6870 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Perio Protect, LLC devices

Submission Details

510(k) Number K031809 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 2003
Decision Date January 23, 2004
Days to Decision 225 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
98d slower than avg
Panel avg: 127d · This submission: 225d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KMT Tray, Fluoride, Disposable
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6870
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.