Cleared Traditional

K020158 - NON-EUGENOL TEMPORARY CEMENT

K020158 is an FDA 510(k) clearance for NON-EUGENOL TEMPORARY CEMENT, manufactured by J. Morita USA, Inc.. The device is a Class 1 Dental device with product code EMB cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K020158 · J. Morita USA, Inc. · Dental device
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Mar 2002
Decision
49d
Days
Class 1
Risk

K020158 is an FDA 510(k) clearance for the NON-EUGENOL TEMPORARY CEMENT. Classified as Zinc Oxide Eugenol (product code EMB), Class I - General Controls.

Submitted by J. Morita USA, Inc. (Washington, US). The FDA issued a Cleared decision on March 7, 2002 after a review of 49 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3275 - 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.

FDA 510(k) Submission Details - K020158

510(k) Number K020158 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 17, 2002
Decision Date March 07, 2002
Days to Decision 49 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
79d faster than avg
Panel avg: 128d · This submission: 49d
Pathway characteristics
Predicate-based equivalence.

EMB Device Classification - Class 1, General Controls

Product Code EMB Zinc Oxide Eugenol
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.3275
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 - EMB Zinc Oxide Eugenol

All 10
Devices cleared under the same product code (EMB) and FDA review panel - the closest regulatory comparables to K020158.
DENTIST IN A BOX DENTAL EMERGENCY KIT PLUS TOOTH TRAUMA CARE KIT
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PROVISA CEM
K073539 · Cavex Holland BV · Jan 2008
DENTAL 911
K941066 · L.A.F. Industries, Inc. · May 1995
DENTIMEDIC DENTAL EMERGENCY KIT
K861681 · Dentimedic · Sep 1986
EUGENOL USP
K862745 · E&D Dental Manufacturing Co. · Jul 1986
K020158 · NON-EUGENOL TEMPORARY CEMENT
Download PDF J. Morita USA, Inc.