Cleared Traditional

K962376 - KREATIV KURING LIGHT SYSTEM

K962376 is an FDA 510(k) clearance for KREATIV KURING LIGHT SYSTEM, manufactured by Kreativ, Inc.. The device is a Class 2 Dental device with product code EBF cleared through the Traditional 510(k) pathway after a 274-day FDA review.

K962376 · Kreativ, Inc. · Dental device
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Mar 1997
Decision
274d
Days
Class 2
Risk

K962376 is an FDA 510(k) clearance for the KREATIV KURING LIGHT SYSTEM. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Kreativ, Inc. (Albany, US). The FDA issued a Cleared decision on March 21, 1997 after a review of 274 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3690 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Kreativ, Inc. devices

FDA 510(k) Submission Details - K962376

510(k) Number K962376 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 1996
Decision Date March 21, 1997
Days to Decision 274 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
147d slower than avg
Panel avg: 127d · This submission: 274d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBF Device Classification - Class 2, Special Controls

Product Code EBF Material, Tooth Shade, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3690
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 - EBF Material, Tooth Shade, Resin

All 724
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K962376.
3M SUSTEL DENTAL SYSTEM
K970500 · 3M Company · Apr 1997
EDTA CAVIT
K970246 · Karolinski · Apr 1997
FOUNDATION INDIRECT COMPOSITE RESIN
K970495 · Sybron Dental Specialties, Inc. · Apr 1997
WHITE CORE
K964931 · Bisco, Inc. · Feb 1997
ULTRA-ETCH STAT
K965060 · Ultradent Products, Inc. · Jan 1997
TETRIC CERAM
K964285 · Ivoclar North America, Inc. · Jan 1997