Cleared Traditional

K031809 - PERIO PROTECT TRAY

K031809 is an FDA 510(k) clearance for PERIO PROTECT TRAY, manufactured by Perio Protect, LLC. The device is a Class 1 Dental device with product code KMT cleared through the Traditional 510(k) pathway after a 225-day FDA review.

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

FDA 510(k) Submission Details - K031809

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.

KMT Device Classification - Class 1, General Controls

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.