Cleared Traditional

AIGIS-SOFT (K024136) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K024136 · Sb Lucius, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2003
Decision
84d
Days
Class 2
Risk

K024136 is an FDA 510(k) clearance for the AIGIS-SOFT. Classified as Alloy, Gold-based Noble Metal (product code EJT), Class II - Special Controls.

Submitted by Sb Lucius, Inc. (Anaheim, US). The FDA issued a Cleared decision on March 10, 2003 after a review of 84 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 Sb Lucius, Inc. devices

Submission Details

510(k) Number K024136 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 2002
Decision Date March 10, 2003
Days to Decision 84 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 127d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 208
Devices cleared under the same product code (EJT) and FDA review panel - the closest regulatory comparables to K024136.
ORION E ALLOY
K032316 · Dentsply Intl. · Sep 2003
ORION GX ALLOY
K032317 · Dentsply Intl. · Sep 2003
285 SL
K961352 · Argen Precious Metals, Inc. · May 1996
ARGELITE 52+
K961211 · Argen Precious Metals, Inc. · Apr 1996
ARGEDENT 40(GOLD-PALLADIUM-SILVER ALLOY FOR PORCELAIN APPLICATION)
K961285 · Argen Precious Metals, Inc. · Apr 1996
ARGISTAR 74
K954362 · Argen Precious Metals, Inc. · Oct 1995