Cleared Traditional

K982259 - CHROMA ZONE COLOR STAIN

K982259 is an FDA 510(k) clearance for CHROMA ZONE COLOR STAIN, manufactured by Kuraray America, Inc.. The device is a Class 2 Dental device with product code EBF cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K982259 · Kuraray America, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1998
Decision
88d
Days
Class 2
Risk

K982259 is an FDA 510(k) clearance for the CHROMA ZONE COLOR STAIN. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Kuraray America, Inc. (New York, US). The FDA issued a Cleared decision on September 22, 1998 after a review of 88 days - a notably fast clearance 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: 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 Kuraray America, Inc. devices

FDA 510(k) Submission Details - K982259

510(k) Number K982259 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 1998
Decision Date September 22, 1998
Days to Decision 88 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 127d · This submission: 88d
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 711
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K982259.
LOW VISCOSITY COMPOSITE TEMPORARY (PROVISIONAL) MATERIAL
K980800 · Cosmedent, Inc. · Nov 1998
ELAN-2
K983091 · Kerr Dental Materials Center · Oct 1998
STERNOMEGA BONDING AGENT, STERNOMEGA COMPOSITE LC, STERNOMEGA COMPOMER LC
K982692 · Sterngold/Implamed · Oct 1998
SPECTRUM 800 CURING UNIT
K982318 · Dentsply Intl. · Sep 1998
RENEW
K982729 · Bisco, Inc. · Sep 1998
PYRAMID
K982645 · Bisco, Inc. · Sep 1998