Cleared Traditional

K840084 - COLTENE BRILLIANT LUX

K840084 is an FDA 510(k) clearance for COLTENE BRILLIANT LUX, manufactured by Bauer, Cheng & Associates, Inc.. The device is a Class 2 Dental device with product code EBF cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K840084 · Bauer, Cheng & Associates, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1984
Decision
80d
Days
Class 2
Risk

K840084 is an FDA 510(k) clearance for the COLTENE BRILLIANT LUX. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Bauer, Cheng & Associates, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 30, 1984 after a review of 80 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 Bauer, Cheng & Associates, Inc. devices

FDA 510(k) Submission Details - K840084

510(k) Number K840084 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 10, 1984
Decision Date March 30, 1984
Days to Decision 80 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 128d · This submission: 80d
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 820
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K840084.
LIGHT CURED RESIN BONDED CERAMIC
K833797 · 3M Company · Apr 1984
ESTIC MICROFILL
K840176 · Kulzer, Inc. · Apr 1984
PRE-LOADED C-R TUBES FOR SYRINGE
K833725 · Centrix, Inc. · Mar 1984
REMBRANDT SHADE MODIFICATION KIT
K841111 · Den-Mat Corp. · Mar 1984
CURAY-MATCH PAINT-ON COMPOSITE RESTOR
K833810 · Scientific Pharmaceuticals, Inc. · Feb 1984
MATERIAL TOOTHSADE RESIN
K834247 · Scientific Pharmaceuticals, Inc. · Feb 1984