Cleared Traditional

K896693 - FLEXI-CAST CROWN CORE SYSTEM (FDA 510(k) Clearance)

Class I Dental device.

K896693 · Essential Dental Systems, Inc. · Dental device
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Feb 1990
Decision
78d
Days
Class 1
Risk

K896693 is an FDA 510(k) clearance for the FLEXI-CAST CROWN CORE SYSTEM. Classified as Post, Root Canal (product code ELR), Class I - General Controls.

Submitted by Essential Dental Systems, Inc. (New York, US). The FDA issued a Cleared decision on February 14, 1990 after a review of 78 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3810 - 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 Essential Dental Systems, Inc. devices

Submission Details

510(k) Number K896693 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 28, 1989
Decision Date February 14, 1990
Days to Decision 78 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 127d · This submission: 78d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code ELR Post, Root Canal
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.3810
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.