Cleared Traditional

K925331 - CORRECT AND CORRECT FIT II

K925331 is an FDA 510(k) clearance for CORRECT AND CORRECT FIT II, manufactured by Jeneric/Pentron, Inc.. The device is a Class 2 Dental device with product code EJS cleared through the Traditional 510(k) pathway after a 218-day FDA review.

K925331 · Jeneric/Pentron, Inc. · Dental device
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May 1993
Decision
218d
Days
Class 2
Risk

K925331 is an FDA 510(k) clearance for the CORRECT AND CORRECT FIT II. Classified as Alloy, Other Noble Metal (product code EJS), Class II - Special Controls.

Submitted by Jeneric/Pentron, Inc. (Wallingford, US). The FDA issued a Cleared decision on May 27, 1993 after a review of 218 days - an extended review 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: 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 Jeneric/Pentron, Inc. devices

FDA 510(k) Submission Details - K925331

510(k) Number K925331 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 1992
Decision Date May 27, 1993
Days to Decision 218 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
91d slower than avg
Panel avg: 127d · This submission: 218d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EJS Device Classification - Class 2, Special Controls

Product Code EJS Alloy, Other 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 - EJS Alloy, Other Noble Metal

All 156
Devices cleared under the same product code (EJS) and FDA review panel - the closest regulatory comparables to K925331.
CU-FREE & LTA
K934757 · Jeneric/Pentron, Inc. · Feb 1994
ARGELITE A
K934773 · Argen Precious Metals, Inc. · Dec 1993
VS 1A
K933563 · Metalor Dental USA Corp. · Oct 1993
BIO C & B
K926146 · Jeneric/Pentron, Inc. · May 1993
GOLD-PLATINUM BASED CASTING ALLOY
K926147 · Jeneric/Pentron, Inc. · May 1993
NUGOLD 2%
K926145 · Jeneric/Pentron, Inc. · May 1993