Cleared Traditional

K023751 - EXAJET

K023751 is the FDA 510(k) clearance for EXAJET by GC America, Inc.. It is a Class 2 Dental device (product code ELW) cleared through the Traditional 510(k) pathway after a 75-day FDA review.

K023751 · GC America, Inc. · Dental device
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Jan 2003
Decision
75d
Days
Class 2
Risk

K023751 is an FDA 510(k) clearance for the EXAJET. 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 22, 2003 after a review of 75 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

Submission Details

510(k) Number K023751 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 2002
Decision Date January 22, 2003
Days to Decision 75 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
52d faster than avg
Panel avg: 127d · This submission: 75d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 140
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K023751.
FIT CHECKER II
K032289 · GC America, Inc. · Oct 2003
ALGINATE IMPRESSION MATERIAL III (FAST & REGULAR)
K031439 · Harry J. Bosworth Co. · Oct 2003
P2 POLYETHER
K030318 · Heraeus Kulzer, Inc. · Apr 2003
ISO FUNCTIONAL
K022430 · GC America, Inc. · Oct 2002
REGISTRADO X-TRA
K022066 · Voco GmbH · Aug 2002
AQUASIL ULTRA MONOPHASE/HEAVY/LV SMART WETTING IMPRESSION MATERIAL
K021416 · Dentsply Intl. · May 2002