Cleared Traditional

K882915 - FORTIFY

K882915 is an FDA 510(k) clearance for FORTIFY, manufactured by Bisco, Inc.. The device is a Class 2 Dental device with 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

FDA 510(k) Submission Details - K882915

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.

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 782
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
PROSTHODENT VL
K881903 · Lee Pharmaceuticals · Jul 1988
CLEARFIL PHOTO CORE
K882006 · Kuraray Co. · Jun 1988
G-CERA PORCELAIN BOND
K880765 · G-C Intl. Corp. · Apr 1988