Cleared Traditional

K875256 - BISCOLOR

K875256 is the FDA 510(k) clearance for BISCOLOR by Bisco, Inc.. It is a Class 2 Dental device (product code EBF) cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K875256 · Bisco, Inc. · Dental device
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Feb 1988
Decision
66d
Days
Class 2
Risk

K875256 is an FDA 510(k) clearance for the BISCOLOR. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Bisco, Inc. (Downers Grove, US). The FDA issued a Cleared decision on February 26, 1988 after a review of 66 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 K875256 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 1987
Decision Date February 26, 1988
Days to Decision 66 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
61d faster than avg
Panel avg: 127d · This submission: 66d
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 K875256.
LUMINBOND, BONDING AND CEMENTATION SYSTEM
K883392 · Scientific Pharmaceuticals, Inc. · Oct 1988
FORTIFY
K882915 · Bisco, Inc. · Aug 1988
PORCELAIN VENEER RESIN CEMENT W/DUAL CURE CATALYST
K875313 · Bisco, Inc. · Mar 1988
SILUX PLUS LIGHT CURED RESTORATIVE MATERIAL
K872444 · 3M Company · Sep 1987
SYNERGY
K872890 · Scientific Pharmaceuticals, Inc. · Aug 1987
DENTIN ADHESIVE
K872907 · Dentsply Intl. · Aug 1987