Cleared Traditional

K010176 - CALEX CONDITIONER

K010176 is an FDA 510(k) clearance for CALEX CONDITIONER, manufactured by Stephen M Koral, Dmd. The device is a Class 2 Dental device with product code EJK cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K010176 · Stephen M Koral, Dmd · Dental device
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Mar 2001
Decision
68d
Days
Class 2
Risk

K010176 is an FDA 510(k) clearance for the CALEX CONDITIONER. Classified as Liner, Cavity, Calcium Hydroxide (product code EJK), Class II - Special Controls.

Submitted by Stephen M Koral, Dmd (Boulder, US). The FDA issued a Cleared decision on March 27, 2001 after a review of 68 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3250 - 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

FDA 510(k) Submission Details - K010176

510(k) Number K010176 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 2001
Decision Date March 27, 2001
Days to Decision 68 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
59d faster than avg
Panel avg: 127d · This submission: 68d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EJK Device Classification - Class 2, Special Controls

Product Code EJK Liner, Cavity, Calcium Hydroxide
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3250
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 - EJK Liner, Cavity, Calcium Hydroxide

All 61
Devices cleared under the same product code (EJK) and FDA review panel - the closest regulatory comparables to K010176.
BISBLOCK
K033521 · Bisco, Inc. · Jan 2004
D/SENSE 1-STEP
K021146 · Centrix, Inc. · Jul 2002
LIFE 2
K012717 · Sybron Dental Specialties, Inc. · Oct 2001
CALCIJECT
K001050 · Centrix, Inc. · Jul 2000
SUPER SEAL
K983477 · Phoenix Dental, Inc. · Dec 1998
ROEKO CALCIUM HYDROXIDE POINTS
K973539 · Roeko USA, Inc. · Oct 1997