Cleared Traditional

K882915 - FORTIFY

K882915 is the FDA 510(k) clearance for FORTIFY by Bisco, Inc.. It is a Class 2 Dental device (product code EBF) cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K882915 · Bisco, Inc. · Dental device
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Aug 1988
Decision
31d
Days
Class 2
Risk

K882915 is an FDA 510(k) clearance for the FORTIFY. 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 August 12, 1988 after a review of 31 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 K882915 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 1988
Decision Date August 12, 1988
Days to Decision 31 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
96d faster than avg
Panel avg: 127d · This submission: 31d
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 K882915.
FIBERLITE, FIBERLITE HS AND FIBERSEAL
K884038 · Jeneric/Pentron, Inc. · Dec 1988
VISIO-PERL
K882566 · Espe GmbH (Us) · Oct 1988
LUMINBOND, BONDING AND CEMENTATION SYSTEM
K883392 · Scientific Pharmaceuticals, Inc. · Oct 1988
PORCELAIN VENEER RESIN CEMENT W/DUAL CURE CATALYST
K875313 · Bisco, Inc. · Mar 1988
BISCOLOR
K875256 · Bisco, Inc. · Feb 1988
SILUX PLUS LIGHT CURED RESTORATIVE MATERIAL
K872444 · 3M Company · Sep 1987