Cleared Traditional

K940565 - COE-SOFT LC

K940565 is an FDA 510(k) clearance for COE-SOFT LC, manufactured by GC America, Inc.. The device is a Class 2 Dental device with product code EBI cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K940565 · GC America, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1994
Decision
85d
Days
Class 2
Risk

K940565 is an FDA 510(k) clearance for the COE-SOFT LC. Classified as Resin, Denture, Relining, Repairing, Rebasing (product code EBI), Class II - Special Controls.

Submitted by GC America, Inc. (Alsip, US). The FDA issued a Cleared decision on May 4, 1994 after a review of 85 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3760 - 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 - K940565

510(k) Number K940565 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 1994
Decision Date May 04, 1994
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.

EBI Device Classification - Class 2, Special Controls

Product Code EBI Resin, Denture, Relining, Repairing, Rebasing
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3760
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 - EBI Resin, Denture, Relining, Repairing, Rebasing

All 239
Devices cleared under the same product code (EBI) and FDA review panel - the closest regulatory comparables to K940565.
PRECISE DENTURE BASE RESIN
K952351 · Dentsply Intl. · Jul 1995
SEALDENT
K944466 · Scientific Pharmaceuticals, Inc. · Mar 1995
HARRY J. BOSWORTH RESIN I.
K946317 · Harry J. Bosworth Co. · Feb 1995
KOOLINER II
K935261 · GC America, Inc. · Jan 1994
REBARON LC
K930939 · GC America, Inc. · Jan 1994
ALPHA-DENT TISSUE CONDITIONER AND TEMPORARY RELINER
K934248 · Wallace A. Erickson & Co. · Dec 1993