Cleared Traditional

NEOCALEX (K013993) - FDA 510(k) Clearance

Class I Dental device.

K013993 · Stephen M Koral, Dmd · Dental device
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Feb 2002
Decision
80d
Days
Class 1
Risk

K013993 is an FDA 510(k) clearance for the NEOCALEX. Classified as Carver, Wax, Dental (product code EIK), Class I - General Controls.

Submitted by Stephen M Koral, Dmd (Boulder, US). The FDA issued a Cleared decision on February 22, 2002 after a review of 80 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4565 - 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 Stephen M Koral, Dmd devices

Submission Details

510(k) Number K013993 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 2001
Decision Date February 22, 2002
Days to Decision 80 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
47d faster than avg
Panel avg: 127d · This submission: 80d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EIK Carver, Wax, Dental
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4565
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.