Cleared Traditional

K901999 - FUJI LINING CEMENT LIGHT CURE

K901999 is an FDA 510(k) clearance for FUJI LINING CEMENT LIGHT CURE, manufactured by G-C Intl. Corp.. 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.

K901999 · G-C Intl. Corp. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1990
Decision
90d
Days
Class 2
Risk

K901999 is an FDA 510(k) clearance for the FUJI LINING CEMENT LIGHT CURE. Classified as Liner, Cavity, Calcium Hydroxide (product code EJK), Class II - Special Controls.

Submitted by G-C Intl. Corp. (Scottsdale, US). The FDA issued a Cleared decision on July 31, 1990 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 G-C Intl. Corp. devices

FDA 510(k) Submission Details - K901999

510(k) Number K901999 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 1990
Decision Date July 31, 1990
Days to Decision 90 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
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 50
Devices cleared under the same product code (EJK) and FDA review panel - the closest regulatory comparables to K901999.
VLC GLASS IONOMER LINER
K911244 · Dentsply Intl. · Jun 1991
PHOTAC-BOND
K904096 · Espe GmbH (Us) · Nov 1990
PHOTAC-BOND APLICAP
K904097 · Espe GmbH (Us) · Nov 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