Cleared Traditional

K143140 - G-Premio BOND

K143140 is an FDA 510(k) clearance for G-Premio BOND, manufactured by GC America, Inc.. The device is a Class 2 Dental device with product code KLE cleared through the Traditional 510(k) pathway after a 168-day FDA review.

K143140 · GC America, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2015
Decision
168d
Days
Class 2
Risk

K143140 is an FDA 510(k) clearance for the G-Premio BOND. Classified as Agent, Tooth Bonding, Resin (product code KLE), Class II - Special Controls.

Submitted by GC America, Inc. (Alsip, US). The FDA issued a Cleared decision on April 20, 2015 after a review of 168 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3200 - 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

FDA 510(k) Submission Details - K143140

510(k) Number K143140 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 2014
Decision Date April 20, 2015
Days to Decision 168 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
41d slower than avg
Panel avg: 127d · This submission: 168d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KLE Device Classification - Class 2, Special Controls

Product Code KLE Agent, Tooth Bonding, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3200
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 - KLE Agent, Tooth Bonding, Resin

All 343
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K143140.
Prime&Bond Elect Universal Dental Adhesive
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K150703 · Kuraray Noritake Dental, Inc. · Aug 2015
Monobond Etch & Prime
K150164 · Ivoclar Vivadent, AG · Apr 2015
EAZY PRIMER
K142848 · Parkell, Inc. · Feb 2015
PREMIER ETCH
K141839 · Premier Dental Products Co. · Nov 2014