Cleared Traditional

FLEXI-FLOW CEMENT NATURAL (K922249) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K922249 · Essential Dental Systems, Inc. · Dental device
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Jan 1994
Decision
630d
Days
Class 2
Risk

K922249 is an FDA 510(k) clearance for the FLEXI-FLOW CEMENT NATURAL. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by Essential Dental Systems, Inc. (Great Neck, US). The FDA issued a Cleared decision on January 26, 1994 after a review of 630 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

View all Essential Dental Systems, Inc. devices

Submission Details

510(k) Number K922249 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 1992
Decision Date January 26, 1994
Days to Decision 630 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
503d slower than avg
Panel avg: 127d · This submission: 630d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EMA Cement, Dental
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3275
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - EMA Cement, Dental

All 136
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K922249.
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3M VITREMER LUTING CEMENT
K933139 · 3M Company · Jan 1994
VARIGLASS VLC GLASS IONOMER
K931229 · Dentsply Intl. · Jul 1993