Cleared Special

K070698 - COE COMFORT

K070698 is the FDA 510(k) clearance for COE COMFORT by GC America, Inc.. It is a Class 2 Dental device (product code EBI) cleared through the Special 510(k) pathway after a 16-day FDA review.

K070698 · GC America, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2007
Decision
16d
Days
Class 2
Risk

K070698 is an FDA 510(k) clearance for the COE COMFORT. 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 March 29, 2007 after a review of 16 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all GC America, Inc. devices

Submission Details

510(k) Number K070698 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 2007
Decision Date March 29, 2007
Days to Decision 16 days
Submission Type Special
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
111d faster than avg
Panel avg: 127d · This submission: 16d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 140
Devices cleared under the same product code (EBI) and FDA review panel - the closest regulatory comparables to K070698.
GRANDTEC
K102347 · Voco GmbH · Oct 2010
ION DENTAL RESIN SYSTEM
K072713 · Dentsply International, Inc. · Oct 2007
COE SOFT
K070697 · GC America, Inc. · Mar 2007
SILKLINE SOFT RELINING KIT, MODEL 28-100100
K060844 · J. Morita USA, Inc. · Jun 2006
MUCOHARD
K053516 · Parkell, Inc. · Jan 2006
NATURE-CRYL HI PLUS
K051358 · GC America, Inc. · Jul 2005