Cleared Traditional

K851459 - VISILUX 2 VISIBLE LIGHT CURING UNIT

K851459 is an FDA 510(k) clearance for VISILUX 2 VISIBLE LIGHT CURING UNIT, manufactured by 3M Company. The device is a Class 2 Dental device with product code EBF cleared through the Traditional 510(k) pathway after a 40-day FDA review.

K851459 · 3M Company · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1985
Decision
40d
Days
Class 2
Risk

K851459 is an FDA 510(k) clearance for the VISILUX 2 VISIBLE LIGHT CURING UNIT. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by 3M Company (Cottae Grove, US). The FDA issued a Cleared decision on May 21, 1985 after a review of 40 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 3M Company devices

FDA 510(k) Submission Details - K851459

510(k) Number K851459 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 1985
Decision Date May 21, 1985
Days to Decision 40 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
87d faster than avg
Panel avg: 127d · This submission: 40d
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 785
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K851459.
ETEN-GEL
K852658 · Dentsply Intl. · Jul 1985
PHOTO CURING LIGHT
K852151 · Dentsply Intl. · Jul 1985
DISTALITE POSTERIA DENTAL RESTORATIVE
K852344 · Johnson & Johnson Professionals, Inc. · Jul 1985
KULZER DENTIN ADHESIVE
K850965 · Kulzer, Inc. · Apr 1985
TRIAD C & B MATERIAL
K850911 · Dentsply Intl. · Apr 1985
PHOTO CLEARFIL A. A LIGHT CURED ADHES. DENTAL REST
K850824 · Kuraray Co. · Apr 1985