Cleared Traditional

K023499 - GOLD CORE PLUS

K023499 is an FDA 510(k) clearance for GOLD CORE PLUS, manufactured by Pentron Laboratory Technologies. The device is a Class 2 Dental device with product code EJH cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K023499 · Pentron Laboratory Technologies · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2003
Decision
87d
Days
Class 2
Risk

K023499 is an FDA 510(k) clearance for the GOLD CORE PLUS. Classified as Alloy, Metal, Base (product code EJH), Class II - Special Controls.

Submitted by Pentron Laboratory Technologies (Wallingford, US). The FDA issued a Cleared decision on January 13, 2003 after a review of 87 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3710 - 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.

FDA 510(k) Submission Details - K023499

510(k) Number K023499 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 2002
Decision Date January 13, 2003
Days to Decision 87 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 faster than avg
Panel avg: 128d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EJH Device Classification - Class 2, Special Controls

Product Code EJH Alloy, Metal, Base
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3710
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 - EJH Alloy, Metal, Base

All 151
Devices cleared under the same product code (EJH) and FDA review panel - the closest regulatory comparables to K023499.
CERACAST-V
K030416 · Mountain Medico, Inc. · Apr 2003
SUPERBOND
K030161 · American Dent-All, Inc. · Mar 2003
KAVO EVEREST TITANBLANK
K024214 · Kavo America · Mar 2003
JEWEL CAST PLUS
K023502 · Pentron Laboratory Technologies · Dec 2002
BIOLOY
K023477 · Neirynck & Vogt NV · Dec 2002
CERALOY
K021971 · Neirynck & Vogt NV · Aug 2002
K023499 · GOLD CORE PLUS
Download PDF FDA Summary Pentron Laboratory Te…