Cleared Traditional

K021038 - GC ELITE CEMENT 100

K021038 is the FDA 510(k) clearance for GC ELITE CEMENT 100 by GC America, Inc.. It is a Class 2 Dental device (product code EMA) cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K021038 · GC America, Inc. · Dental device
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May 2002
Decision
32d
Days
Class 2
Risk

K021038 is an FDA 510(k) clearance for the GC ELITE CEMENT 100. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by GC America, Inc. (Alsip, US). The FDA issued a Cleared decision on May 3, 2002 after a review of 32 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3275 - 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 GC America, Inc. devices

Submission Details

510(k) Number K021038 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 2002
Decision Date May 03, 2002
Days to Decision 32 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 127d · This submission: 32d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EMA Cement, Dental
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3275
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 - EMA Cement, Dental

All 254
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K021038.
AGC CEM
K030168 · Wieland Dental + Technik GmbH & Co. KG · Mar 2003
TEMPORARY CEMENT-DC010002
K023727 · GC America, Inc. · Jan 2003
RELYX RMGIP
K022476 · 3M Company · Aug 2002
GC FUJI LINING LC PASTE PAK
K020117 · GC America, Inc. · Feb 2002
SCI-PHARM POST SECURE
K013555 · Scientific Pharmaceuticals, Inc. · Jan 2002
NEXUS 2 CLEAR
K013609 · Sybron Dental Specialties, Inc. · Jan 2002