Cleared Traditional

K922957 - PARAGON

K922957 is an FDA 510(k) clearance for PARAGON, 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 88-day FDA review.

K922957 · Jeneric/Pentron, Inc. · Dental device
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Sep 1992
Decision
88d
Days
Class 2
Risk

K922957 is an FDA 510(k) clearance for the PARAGON. 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 September 14, 1992 after a review of 88 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 - K922957

510(k) Number K922957 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 1992
Decision Date September 14, 1992
Days to Decision 88 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
39d faster than avg
Panel avg: 127d · This submission: 88d
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 K922957.
ZENON PLUS
K922955 · Jeneric/Pentron, Inc. · Dec 1992
GDC 3445
K925273 · Deringer-Ney, Inc. · Dec 1992
KB40-KF
K922956 · Jeneric/Pentron, Inc. · Sep 1992
ACCU-STAR
K922446 · J.F. Jelenko & Co., Inc. · Aug 1992
BENCHMARK III
K922447 · J.F. Jelenko & Co., Inc. · Aug 1992
BENCHMARK I
K922448 · J.F. Jelenko & Co., Inc. · Aug 1992