Cleared Traditional

K926419 - CALCICUR

K926419 is the FDA 510(k) clearance for CALCICUR by Voco GmbH. It is a Class 2 Dental device (product code EJK) cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K926419 · Voco GmbH · Dental device
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Mar 1993
Decision
98d
Days
Class 2
Risk

K926419 is an FDA 510(k) clearance for the CALCICUR. Classified as Liner, Cavity, Calcium Hydroxide (product code EJK), Class II - Special Controls.

Submitted by Voco GmbH (St. Louis, US). The FDA issued a Cleared decision on March 31, 1993 after a review of 98 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Voco GmbH devices

Submission Details

510(k) Number K926419 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 1992
Decision Date March 31, 1993
Days to Decision 98 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
29d faster than avg
Panel avg: 127d · This submission: 98d
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 K926419.
NEEDLETUBE SYRINGE CARTRTIDGE
K933507 · Centrix, Inc. · Jan 1994
STERIBASE (ACCUBASE)
K933999 · Centrix, Inc. · Jan 1994
VIVAGLASS LINER
K931502 · Ivoclar North America, Inc. · Jul 1993
LIGHT CURE DENTIN AND LINER BASE PRODUCT LINE
K921408 · Ultradent Products, Inc. · Nov 1992
CALCIMOL LC
K924182 · Voco GmbH · Oct 1992
CALCIMOL
K923849 · Voco GmbH · Sep 1992