Cleared Traditional

K994077 - AROMA FINE (NORMAL AND FAST SET)

K994077 is an FDA 510(k) clearance for AROMA FINE (NORMAL AND FAST SET), 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 56-day FDA review.

K994077 · GC America, Inc. · Dental device
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Jan 2000
Decision
56d
Days
Class 2
Risk

K994077 is an FDA 510(k) clearance for the AROMA FINE (NORMAL AND FAST SET). 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, 2000 after a review of 56 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 - K994077

510(k) Number K994077 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 1999
Decision Date January 27, 2000
Days to Decision 56 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
71d faster than avg
Panel avg: 127d · This submission: 56d
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 K994077.
CEREC 3
K994172 · Sirona Dental Systems GmbH · Feb 2000
IMPREGUM PENTA M MONOSOFT
K994192 · Espe Dental AG · Jan 2000
IMPREGUM PENTA DUOSOFT
K994193 · Espe Dental AG · Jan 2000
IMPREGUM GARANT L DUOSOFT
K994190 · Espe Dental AG · Jan 2000
TRAY-LINK
K992001 · Silicon-Und Composite Spezialitaten GmbH · Nov 1999
IMPREGUM F
K992895 · Espe Dental AG · Sep 1999