Cleared Traditional

VISIBLE LIGHT CURE CALCIUM HYDROXIDE LINER (K884949) - FDA 510(k) Clearance

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

K884949 · Ortho Source · Dental device
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Feb 1989
Decision
90d
Days
Class 2
Risk

K884949 is an FDA 510(k) clearance for the VISIBLE LIGHT CURE CALCIUM HYDROXIDE LINER. Classified as Liner, Cavity, Calcium Hydroxide (product code EJK), Class II - Special Controls.

Submitted by Ortho Source (North Hollywood, US). The FDA issued a Cleared decision on February 23, 1989 after a review of 90 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 Ortho Source devices

Submission Details

510(k) Number K884949 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 1988
Decision Date February 23, 1989
Days to Decision 90 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 127d · This submission: 90d
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 K884949.
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