Cleared Traditional

K042888 - DEMETRON IDS CURING LIGHT

K042888 is an FDA 510(k) clearance for DEMETRON IDS CURING LIGHT, manufactured by Kerr Corp.. The device is a Class 2 Dental device with product code EBZ cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K042888 · Kerr Corp. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2004
Decision
22d
Days
Class 2
Risk

K042888 is an FDA 510(k) clearance for the DEMETRON IDS CURING LIGHT. Classified as Activator, Ultraviolet, For Polymerization (product code EBZ), Class II - Special Controls.

Submitted by Kerr Corp. (Orange, US). The FDA issued a Cleared decision on November 10, 2004 after a review of 22 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6070 - 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.

FDA 510(k) Submission Details - K042888

510(k) Number K042888 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 2004
Decision Date November 10, 2004
Days to Decision 22 days
Submission Type Traditional
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
106d faster than avg
Panel avg: 128d · This submission: 22d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBZ Device Classification - Class 2, Special Controls

Product Code EBZ Activator, Ultraviolet, For Polymerization
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.6070
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 - EBZ Activator, Ultraviolet, For Polymerization

All 202
Devices cleared under the same product code (EBZ) and FDA review panel - the closest regulatory comparables to K042888.
G-LIGHT
K050059 · GC America, Inc. · Feb 2005
DVI CURING LIGHT
K043530 · Designs For Vision, Inc. · Jan 2005
NOVA-PULSE
K043302 · Nova Ranger, Inc. · Jan 2005
SAVEDENT BLUE
K042196 · Denfotex Light Systems, Ltd. · Nov 2004
CYBIRD LED CURING LIGHT
K042703 · Dxm Co., Ltd. · Oct 2004
TRANSLUX POWER BLUE
K042199 · Heraeus Kulzer,GmbH · Sep 2004
K042888 · DEMETRON IDS CURING LIGHT
Download PDF FDA Summary Kerr Corp.