Cleared Traditional

K153231 - G-Cem LinkForce, Dual Cure Activator, Try-In Paste, Multi Primer

K153231 is an FDA 510(k) clearance for G-Cem LinkForce, manufactured by GC America, Inc.. The device is a Class 2 Dental device with product code EMA cleared through the Traditional 510(k) pathway after a 240-day FDA review.

K153231 · GC America, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2016
Decision
240d
Days
Class 2
Risk

K153231 is an FDA 510(k) clearance for the G-Cem LinkForce, Dual Cure Activator, Try-In Paste, Multi Primer. 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 July 6, 2016 after a review of 240 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.

FDA 510(k) Submission Details - K153231

510(k) Number K153231 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 2015
Decision Date July 06, 2016
Days to Decision 240 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
112d slower than avg
Panel avg: 128d · This submission: 240d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EMA Device Classification - Class 2, Special Controls

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 460
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K153231.
TempoCem Clear
K160443 · Dmg USA, Inc. · Sep 2016
IonoStar Plus
K160774 · Voco GmbH · Aug 2016
TheraCem
K161256 · Bisco, Inc. · Jul 2016
ORAL BOND
K142130 · Steiner Laboratories · Jun 2016
Ketac Universal Aplicap
K153174 · 3M Deutschland GmbH · Apr 2016
PackFil Dual Cured Resin Modified Glass Ionomer Restorative Cement
K152652 · Gaia Dental Products, Inc. · Apr 2016