Cleared Traditional

K915353 - MATRX MEDICAL MAXIMIZER 1000 AND 2000 V...

K915353 is the FDA 510(k) clearance for MATRX MEDICAL MAXIMIZER 1000 AND 2000 V... by Matrix Medica, Inc.. It is a Class 1 Dental device (product code EIA) cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K915353 · Matrix Medica, Inc. · Dental device
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Dec 1991
Decision
31d
Days
Class 1
Risk

K915353 is an FDA 510(k) clearance for the MATRX MEDICAL MAXIMIZER 1000 AND 2000 VACUUM PUMP. 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 December 27, 1991 after a review of 31 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Matrix Medica, Inc. devices

Submission Details

510(k) Number K915353 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 1991
Decision Date December 27, 1991
Days to Decision 31 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
96d faster than avg
Panel avg: 127d · This submission: 31d
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.

Regulatory Peers - EIA Unit, Operative Dental

All 28
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