Cleared Traditional

K942430 - AGALLOY, DISALLOY, EPSILON AND LAMBDA

K942430 is an FDA 510(k) clearance for AGALLOY, manufactured by Fen Dental Mfg., Inc.. The device is a Class 2 Dental device with product code EJJ cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K942430 · Fen Dental Mfg., Inc. · Dental device
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Jul 1994
Decision
55d
Days
Class 2
Risk

K942430 is an FDA 510(k) clearance for the AGALLOY, DISALLOY, EPSILON AND LAMBDA. Classified as Alloy, Amalgam (product code EJJ), Class II - Special Controls.

Submitted by Fen Dental Mfg., Inc. (Miami, US). The FDA issued a Cleared decision on July 14, 1994 after a review of 55 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3070 - 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 Fen Dental Mfg., Inc. devices

FDA 510(k) Submission Details - K942430

510(k) Number K942430 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 1994
Decision Date July 14, 1994
Days to Decision 55 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 127d · This submission: 55d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EJJ Device Classification - Class 2, Special Controls

Product Code EJJ Alloy, Amalgam
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3070
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 - EJJ Alloy, Amalgam

All 45
Devices cleared under the same product code (EJJ) and FDA review panel - the closest regulatory comparables to K942430.
GALLOY
K955285 · Southern Dental Industries, Inc. · Jan 1996
TYTIN R
K951663 · Kerr Corporation (Danbury) · Jun 1995
TYTIN ADMIX
K951511 · Kerr Corporation (Danbury) · May 1995
SYBRALOY
K940675 · Sybron Dental Specialties, Inc. · Apr 1994
TYTIN
K935535 · Kerr Corporation (Danbury) · Mar 1994
MIRACLE MIX CAPS GLASS IONOMER CEMENT INCAPSULES
K913175 · G-C Intl. Corp. · Dec 1991