Cleared Traditional

K926419 - CALCICUR

K926419 is an FDA 510(k) clearance for CALCICUR, manufactured by Voco GmbH. The device is a Class 2 Dental device with 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

FDA 510(k) Submission Details - K926419

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.

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 60
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