Cleared Traditional

K022430 - ISO FUNCTIONAL

K022430 is an FDA 510(k) clearance for ISO FUNCTIONAL, manufactured by GC America, Inc.. The device is a Class 2 Dental device with product code ELW cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K022430 · GC America, Inc. · Dental device
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Oct 2002
Decision
85d
Days
Class 2
Risk

K022430 is an FDA 510(k) clearance for the ISO FUNCTIONAL. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by GC America, Inc. (Alsip, US). The FDA issued a Cleared decision on October 18, 2002 after a review of 85 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3660 - 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 GC America, Inc. devices

FDA 510(k) Submission Details - K022430

510(k) Number K022430 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 2002
Decision Date October 18, 2002
Days to Decision 85 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
42d faster than avg
Panel avg: 127d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ELW Device Classification - Class 2, Special Controls

Product Code ELW Material, Impression
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3660
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 - ELW Material, Impression

All 306
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K022430.
ZETAPLUS SOFT
K024041 · Zhermack S.P.A. · Dec 2002
TULIP ALGINATE IMPRESSION MATERIAL
K023466 · Cavex Holland BV · Dec 2002
ELITE MONOPHASE
K022653 · Zhermack S.P.A. · Oct 2002
REGISTRADO X-TRA
K022066 · Voco GmbH · Aug 2002
AQUASIL ULTRA MONOPHASE/HEAVY/LV SMART WETTING IMPRESSION MATERIAL
K021416 · Dentsply Intl. · May 2002
AQUASIL ULTRA RIGID SMART WETTING IMPRESSION MATERIAL
K021413 · Dentsply Intl. · May 2002