Cleared Traditional

BASIC CALCIUM HYDROXIDE LINER (K896529) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K896529 · Ivoclar North America, Inc. · Dental device
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Jan 1990
Decision
63d
Days
Class 2
Risk

K896529 is an FDA 510(k) clearance for the BASIC CALCIUM HYDROXIDE LINER. Classified as Liner, Cavity, Calcium Hydroxide (product code EJK), Class II - Special Controls.

Submitted by Ivoclar North America, Inc. (Amherst, US). The FDA issued a Cleared decision on January 16, 1990 after a review of 63 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 Ivoclar North America, Inc. devices

Submission Details

510(k) Number K896529 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 1989
Decision Date January 16, 1990
Days to Decision 63 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 127d · This submission: 63d
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 12
Devices cleared under the same product code (EJK) and FDA review panel - the closest regulatory comparables to K896529.
TheraCal DC
K180344 · Bisco, Inc. · Apr 2018
VLC DYCAL II
K922721 · Dentsply Intl. · Jul 1992
VLC GLASS IONOMER LINER
K911244 · Dentsply Intl. · Jun 1991
GLASS IONOMER BASE
K882751 · Dentsply Intl. · Nov 1988
IMPROVED DYCAL
K820215 · Dentsply Intl. · Mar 1982
MONOJECT PULP-CAPPING MATERIAL
K791088 · Sherwood Medical Co. · Oct 1979