Cleared Traditional

K872243 - PEKALUX(TM)

K872243 is an FDA 510(k) clearance for PEKALUX(TM), 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 26-day FDA review.

K872243 · Columbus Dental Mfg. Co. · Dental device
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Jul 1987
Decision
26d
Days
Class 2
Risk

K872243 is an FDA 510(k) clearance for the PEKALUX(TM). 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 July 7, 1987 after a review of 26 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 - K872243

510(k) Number K872243 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 11, 1987
Decision Date July 07, 1987
Days to Decision 26 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
102d faster than avg
Panel avg: 128d · This submission: 26d
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 K872243.
CLEARFIL FII NEW BOND
K871634 · Kuraray Co. · Jul 1987
CLEARFIL CORE NEW BOND
K871637 · Kuraray Co. · Jul 1987
CLEARFIL POSTERIOR 3
K871635 · Kuraray Co. · Jul 1987
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