Cleared Traditional

K871165 - LUMIFOR(TM) COMPOSITE

K871165 is an FDA 510(k) clearance for LUMIFOR(TM) COMPOSITE, manufactured by Columbus Dental Mfg. Co.. The device is a Class 2 Dental device with product code EBF cleared through the Traditional 510(k) pathway after a 10-day FDA review.

K871165 · Columbus Dental Mfg. Co. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1987
Decision
10d
Days
Class 2
Risk

K871165 is an FDA 510(k) clearance for the LUMIFOR(TM) COMPOSITE. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Columbus Dental Mfg. Co. (St. Louis, US). The FDA issued a Cleared decision on April 3, 1987 after a review of 10 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 Columbus Dental Mfg. Co. devices

FDA 510(k) Submission Details - K871165

510(k) Number K871165 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 1987
Decision Date April 03, 1987
Days to Decision 10 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
118d faster than avg
Panel avg: 128d · This submission: 10d
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 817
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K871165.
SCOTCHBOND 2 ADHESIVE W/SCOTCHPREP DENTIN PRIMER
K872279 · 3M Company · Jul 1987
PERFORM DENTURE BASE RESIN
K871270 · Ipco Corp. · May 1987
ADAPTALITE* PORCELAIN VENEER CEMENTATION SYSTEM
K871295 · Johnson & Johnson Professionals, Inc. · May 1987
ESPE CHELON-SILVER
K865028 · Espe GmbH (Us) · Feb 1987
REMBRANDT PORCELAIN TINTING KIT
K864346 · Den-Mat Corp. · Jan 1987
OPALUX VISIBLE LIGHT CURED ANTERIOR COMPOSITE
K863882 · Coe Laboratories, Inc. · Nov 1986