Cleared Traditional

K120243 - GAM-200

K120243 is the FDA 510(k) clearance for GAM-200 by GC America, Inc.. It is a Class 2 Dental device (product code EMA) cleared through the Traditional 510(k) pathway after a 152-day FDA review.

K120243 · GC America, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2012
Decision
152d
Days
Class 2
Risk

K120243 is an FDA 510(k) clearance for the GAM-200. 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 June 27, 2012 after a review of 152 days - an extended review 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: 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 GC America, Inc. devices

Submission Details

510(k) Number K120243 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 2012
Decision Date June 27, 2012
Days to Decision 152 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
25d slower than avg
Panel avg: 127d · This submission: 152d
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 219
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K120243.
Bifix Temp
K143212 · Voco GmbH · May 2015
IONOSTAR MOLAR
K140993 · Voco GmbH · Oct 2014
MERON APPLICATION CAPSULES
K130421 · Voco GmbH · Aug 2013
HY-BOND RESIGLASS
K111855 · Shofu Dental Corp. · Nov 2011
PERMASHADE VENEER CEMENT
K111836 · Ultradent Products, Inc. · Sep 2011
CLEARTEMP
K111017 · Ultradent Products, Inc. · Jun 2011