Cleared Traditional

K924182 - CALCIMOL LC

K924182 is the FDA 510(k) clearance for CALCIMOL LC by Voco GmbH. It is a Class 2 Dental device (product code EJK) cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K924182 · Voco GmbH · Dental device
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Oct 1992
Decision
58d
Days
Class 2
Risk

K924182 is an FDA 510(k) clearance for the CALCIMOL LC. Classified as Liner, Cavity, Calcium Hydroxide (product code EJK), Class II - Special Controls.

Submitted by Voco GmbH (Denver, US). The FDA issued a Cleared decision on October 16, 1992 after a review of 58 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 Voco GmbH devices

Submission Details

510(k) Number K924182 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 1992
Decision Date October 16, 1992
Days to Decision 58 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
69d faster than avg
Panel avg: 127d · This submission: 58d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 41
Devices cleared under the same product code (EJK) and FDA review panel - the closest regulatory comparables to K924182.
VIVAGLASS LINER
K931502 · Ivoclar North America, Inc. · Jul 1993
CALCICUR
K926419 · Voco GmbH · Mar 1993
LIGHT CURE DENTIN AND LINER BASE PRODUCT LINE
K921408 · Ultradent Products, Inc. · Nov 1992
CALCIMOL
K923849 · Voco GmbH · Sep 1992
VLC DYCAL II
K922721 · Dentsply Intl. · Jul 1992
IONOSEAL
K912495 · Voco GmbH · Jul 1991