Cleared Traditional

K152652 - PackFil Dual Cured Resin Modified Glass...

K152652 is an FDA 510(k) clearance for PackFil Dual Cured Resin Modified Glass..., manufactured by Gaia Dental Products, Inc.. The device is a Class 2 Dental device with product code EMA cleared through the Traditional 510(k) pathway after a 202-day FDA review.

K152652 · Gaia Dental Products, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2016
Decision
202d
Days
Class 2
Risk

K152652 is an FDA 510(k) clearance for the PackFil Dual Cured Resin Modified Glass Ionomer Restorative Cement. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by Gaia Dental Products, Inc. (Meriden, US). The FDA issued a Cleared decision on April 5, 2016 after a review of 202 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 Gaia Dental Products, Inc. devices

FDA 510(k) Submission Details - K152652

510(k) Number K152652 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 2015
Decision Date April 05, 2016
Days to Decision 202 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
75d slower than avg
Panel avg: 127d · This submission: 202d
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 353
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K152652.
IonoStar Plus
K160774 · Voco GmbH · Aug 2016
TheraCem
K161256 · Bisco, Inc. · Jul 2016
G-Cem LinkForce, Dual Cure Activator, Try-In Paste, Multi Primer
K153231 · GC America, Inc. · Jul 2016
PANAVIA V5: Standard Kit (Universal (A2)), Standard Kit (Clear), Introductory Kit (Universal (A2)), Introductory Kit (Clear), Sample Pack (Universal (A2)), Paste (Universal (A2)), Paste (Clear), Paste (Brown (A4)), Paste (White), Paste (Opaque), Try-in Paste (Universal (A2)), Try-in Paste (Clear), Try-in Paste (Brown (A4)), Try-in Paste (White), Try-in Paste (Opaque), Tooth Primer
K150704 · Kuraray Noritake Dental, Inc. · Aug 2015
ESTECEM
K150727 · Tokuyama Dental Corporation · Jun 2015
Bifix Temp
K143212 · Voco GmbH · May 2015