Cleared Traditional

K893219 - MATRX DENTAL UNIT (FDA 510(k) Clearance)

Class I Dental device.

K893219 · Matrix Medica, Inc. · Dental device
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Aug 1989
Decision
102d
Days
Class 1
Risk

K893219 is an FDA 510(k) clearance for the MATRX DENTAL UNIT. Classified as Unit, Operative Dental (product code EIA), Class I - General Controls.

Submitted by Matrix Medica, Inc. (Orchard Park, US). The FDA issued a Cleared decision on August 7, 1989 after a review of 102 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6640 - 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 Matrix Medica, Inc. devices

Submission Details

510(k) Number K893219 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 1989
Decision Date August 07, 1989
Days to Decision 102 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 127d · This submission: 102d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EIA Unit, Operative Dental
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6640
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.

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