Cleared Traditional

OMNI-MATRIX (K930151) - FDA 510(k) Clearance

Class I Dental device.

K930151 · Innovative Technology , Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1993
Decision
254d
Days
Class 1
Risk

K930151 is an FDA 510(k) clearance for the OMNI-MATRIX. Classified as Retainer, Matrix (product code JEP), Class I - General Controls.

Submitted by Innovative Technology , Ltd. (Ontario L3y 1j8, CA). The FDA issued a Cleared decision on September 23, 1993 after a review of 254 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4565 - 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 Innovative Technology , Ltd. devices

Submission Details

510(k) Number K930151 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 12, 1993
Decision Date September 23, 1993
Days to Decision 254 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
127d slower than avg
Panel avg: 127d · This submission: 254d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JEP Retainer, Matrix
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4565
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.