Cleared Traditional

K893219 - MATRX DENTAL UNIT

K893219 is an FDA 510(k) clearance for MATRX DENTAL UNIT, manufactured by Matrix Medica, Inc.. The device is a Class 1 Dental device with product code EIA cleared through the Traditional 510(k) pathway after a 102-day FDA review.

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.

FDA 510(k) Submission Details - K893219

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 128d · This submission: 102d
Pathway characteristics
Predicate-based equivalence.

EIA Device Classification - Class 1, General Controls

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 261
Devices cleared under the same product code (EIA) and FDA review panel - the closest regulatory comparables to K893219.
ISODENT
K894058 · Eurodent, Inc. · Dec 1989
STUDIO UNO
K894061 · Eurodent, Inc. · Nov 1989
ALLPAC(TM) MATERIAL
K894759 · Barrier Concepts, Inc. · Oct 1989
DELIVERY PUMP FOR STERILE IRRIGANT & HANDPIECE DR.
K882526 · Aseptico, Inc. · Dec 1988
DP32 HAND HELD DENTAL PROPHYLAXIS UNIT
K861601 · Stewart J. Lustgarten · Oct 1986
CM-II, CM-I WATER UNIT
K863021 · Sds Dental, Inc. · Oct 1986
K893219 · MATRX DENTAL UNIT
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