Cleared Traditional

K955932 - EXAFLEX IMPRESSION MATERIAL (MODIFICATION)

K955932 is the FDA 510(k) clearance for EXAFLEX IMPRESSION MATERIAL (MODIFICATION) by GC America, Inc.. It is a Class 2 Dental device (product code ELW) cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K955932 · GC America, Inc. · Dental device
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Mar 1996
Decision
89d
Days
Class 2
Risk

K955932 is an FDA 510(k) clearance for the EXAFLEX IMPRESSION MATERIAL (MODIFICATION). 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 March 11, 1996 after a review of 89 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 K955932 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 1995
Decision Date March 11, 1996
Days to Decision 89 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
38d faster than avg
Panel avg: 127d · This submission: 89d
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 K955932.
TRI-PHASIX CHROMATIC ALGINATE
K962741 · Parkell, Inc. · Sep 1996
JELTRATE PLUS ANTIMICROBIAL IMPR. MATERIAL
K952614 · Dentsply Intl. · Aug 1996
BOSWORTH IMPRESSION MATERIAL II
K961201 · Harry J. Bosworth Co. · May 1996
BOSWORTH IMPRESSION MATERIAL I
K960063 · Harry J. Bosworth Co. · Feb 1996
SCAN WHITE 12 ML
K955406 · Vident · Dec 1995
RETRAC
K952728 · Centrix, Inc. · Sep 1995