Cleared Traditional

K043471 - FUSION FAST

K043471 is an FDA 510(k) clearance for FUSION FAST, 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 42-day FDA review.

K043471 · GC America, Inc. · Dental device
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Jan 2005
Decision
42d
Days
Class 2
Risk

K043471 is an FDA 510(k) clearance for the FUSION FAST. 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 January 27, 2005 after a review of 42 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 - K043471

510(k) Number K043471 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 2004
Decision Date January 27, 2005
Days to Decision 42 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
85d faster than avg
Panel avg: 127d · This submission: 42d
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 K043471.
FUSION PUTTY TYPE
K043493 · GC America, Inc. · Mar 2005
GENIE MAGIC MIX ULTRA HYDROPHILIC IMPRESSION MATERIAL
K043054 · Sultan Chemists, Inc. · Feb 2005
RETRACTOFOAM
K050013 · Coltene/Whaledent AG · Feb 2005
HYDROGUM SOFT
K043118 · Zhermack S.P.A. · Jan 2005
FLEXITIME XTREME
K042878 · Heraeus Kulzer, Inc. · Dec 2004
TORPICALGIN
K043131 · Zhermack S.P.A. · Dec 2004