Cleared Traditional

K884949 - VISIBLE LIGHT CURE CALCIUM HYDROXIDE LINER

K884949 is an FDA 510(k) clearance for VISIBLE LIGHT CURE CALCIUM HYDROXIDE LINER, manufactured by Ortho Source. The device is a Class 2 Dental device with product code EJK cleared through the Traditional 510(k) pathway after a 90-day FDA review.

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

FDA 510(k) Submission Details - K884949

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.

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 61
Devices cleared under the same product code (EJK) and FDA review panel - the closest regulatory comparables to K884949.
FUJI LINING CEMENT LIGHT CURE
K901999 · G-C Intl. Corp. · Jul 1990
INTERFACE - CAVITY LINER
K897130 · Scientific Pharmaceuticals, Inc. · Mar 1990
BASIC CALCIUM HYDROXIDE LINER
K896529 · Ivoclar North America, Inc. · Jan 1990
GLASS IONOMER BASE
K882751 · Dentsply Intl. · Nov 1988
ALKALINER
K873882 · Espe GmbH (Us) · Feb 1988
KERR CAVALITE
K872147 · Kerr Corporation (Danbury) · Aug 1987