Cleared Traditional

K842087 - BISFIL-I LIGHT CURABLE POSTERIOR COMPO

K842087 is the FDA 510(k) clearance for BISFIL-I LIGHT CURABLE POSTERIOR COMPO by Bisco, Inc.. It is a Class 2 Dental device (product code EBF) cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K842087 · Bisco, Inc. · Dental device
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Jul 1984
Decision
49d
Days
Class 2
Risk

K842087 is an FDA 510(k) clearance for the BISFIL-I LIGHT CURABLE POSTERIOR COMPO. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Bisco, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 12, 1984 after a review of 49 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 Bisco, Inc. devices

Submission Details

510(k) Number K842087 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 24, 1984
Decision Date July 12, 1984
Days to Decision 49 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
78d faster than avg
Panel avg: 127d · This submission: 49d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 516
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K842087.
DISTALITE POSTERIA DENTAL RESTORATIVE
K852344 · Johnson & Johnson Professionals, Inc. · Jul 1985
VISILUX 2 VISIBLE LIGHT CURING UNIT
K851459 · 3M Company · May 1985
TRIAD C & B MATERIAL
K850911 · Dentsply Intl. · Apr 1985
SCOTCHBOND LIGHT CURED DENTAL ADHES
K841550 · 3M Company · Jun 1984
WUNDERFIL
K841667 · Harry J. Bosworth Co. · May 1984
JOHNSON & JOHNSON POSTERIOR DENTAL (ADAPTIC II)
K841518 · Johnson & Johnson Professionals, Inc. · May 1984