Cleared Traditional

K993175 - GOLD CORE 75

K993175 is an FDA 510(k) clearance for GOLD CORE 75, manufactured by Jeneric/Pentron, Inc.. The device is a Class 2 Dental device with product code EJT cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K993175 · Jeneric/Pentron, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1999
Decision
34d
Days
Class 2
Risk

K993175 is an FDA 510(k) clearance for the GOLD CORE 75. Classified as Alloy, Gold-based Noble Metal (product code EJT), Class II - Special Controls.

Submitted by Jeneric/Pentron, Inc. (Wallingford, US). The FDA issued a Cleared decision on October 26, 1999 after a review of 34 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3060 - 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 - K993175

510(k) Number K993175 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 1999
Decision Date October 26, 1999
Days to Decision 34 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
93d faster than avg
Panel avg: 127d · This submission: 34d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EJT Device Classification - Class 2, Special Controls

Product Code EJT Alloy, Gold-based Noble Metal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3060
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 - EJT Alloy, Gold-based Noble Metal

All 489
Devices cleared under the same product code (EJT) and FDA review panel - the closest regulatory comparables to K993175.
V-SUPRAGOLD, ALLOY NO. 5024
K993507 · Metalor Dental USA Corp. · Dec 1999
V-SUPRA PLUS, ALLOY NO. 5025
K993508 · Metalor Dental USA Corp. · Dec 1999
GOLD CORE 55
K993173 · Jeneric/Pentron, Inc. · Oct 1999
JEL BIOS 10 (CODE NAME RD-1801)
K993136 · J.F. Jelenko & Co., Inc. · Oct 1999
JEL BIOS 18 (CODE NAME RD- 1214)
K993152 · J.F. Jelenko & Co., Inc. · Oct 1999
BIO-97
K991901 · Jeneric/Pentron, Inc. · Sep 1999