Cleared Traditional

K003039 - GOLD CORE II

K003039 is an FDA 510(k) clearance for GOLD CORE II, manufactured by Jeneric/Pentron, Inc.. The device is a Class 2 Dental device with product code EJH cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K003039 · Jeneric/Pentron, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2000
Decision
67d
Days
Class 2
Risk

K003039 is an FDA 510(k) clearance for the GOLD CORE II. Classified as Alloy, Metal, Base (product code EJH), Class II - Special Controls.

Submitted by Jeneric/Pentron, Inc. (Wallingford, US). The FDA issued a Cleared decision on December 5, 2000 after a review of 67 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.

View all Jeneric/Pentron, Inc. devices

FDA 510(k) Submission Details - K003039

510(k) Number K003039 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2000
Decision Date December 05, 2000
Days to Decision 67 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
61d faster than avg
Panel avg: 128d · This submission: 67d
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 117
Devices cleared under the same product code (EJH) and FDA review panel - the closest regulatory comparables to K003039.
AUROFILM NP
K003387 · Metalor Dental USA Corp. · Jan 2001
FLEXICAST
K003509 · American Dent-All, Inc. · Jan 2001
JEWEL CAST III
K003037 · Jeneric/Pentron, Inc. · Dec 2000
SUPER 6
K002300 · Dental Alloy Products, Inc. · Sep 2000
SUPER 14
K002302 · Dental Alloy Products, Inc. · Sep 2000
SUPER 3
K002299 · Dental Alloy Products, Inc. · Sep 2000