Cleared Traditional

K922249 - FLEXI-FLOW CEMENT NATURAL

K922249 is an FDA 510(k) clearance for FLEXI-FLOW CEMENT NATURAL, manufactured by Essential Dental Systems, Inc.. The device is a Class 2 Dental device with product code EMA cleared through the Traditional 510(k) pathway after a 630-day FDA review.

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

FDA 510(k) Submission Details - K922249

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.

EMA Device Classification - Class 2, Special Controls

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 310
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K922249.
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K940546 · Confi-Dental Products Co. · Apr 1994
PANAVIA 21
K933030 · Kuraray Co. · Feb 1994
BISCO COMPOSITE
K940030 · Bisco, Inc. · Feb 1994
PRECEDENT
K934405 · Reliance Orthodontic Products, Inc. · Jan 1994
CRYSTALLINE 'FLUORITE' CORE BUILD-UP MATERIAL
K933199 · Confi-Dental Products Co. · Jan 1994
GC ELITE CEMENT
K935521 · GC America, Inc. · Jan 1994