Cleared Traditional

K934247 - BISCO UNIVERSAL HYBRID COMPOSITE

K934247 is an FDA 510(k) clearance for BISCO UNIVERSAL HYBRID COMPOSITE, 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 91-day FDA review.

K934247 · Bisco, Inc. · Dental device
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Nov 1993
Decision
91d
Days
Class 2
Risk

K934247 is an FDA 510(k) clearance for the BISCO UNIVERSAL HYBRID COMPOSITE. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Bisco, Inc. (Itasca, US). The FDA issued a Cleared decision on November 29, 1993 after a review of 91 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Bisco, Inc. devices

FDA 510(k) Submission Details - K934247

510(k) Number K934247 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 1993
Decision Date November 29, 1993
Days to Decision 91 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 127d · This submission: 91d
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 K934247.
TI-CORE-NATURAL
K922251 · Essential Dental Systems, Inc. · Jan 1994
TI-CORE NEW & IMPROVED
K922252 · Essential Dental Systems, Inc. · Jan 1994
CHARISMA SUPERLIGHT
K935736 · Heraeus Kulzer, Inc. · Jan 1994
STO2P
K934611 · Ivoclar North America, Inc. · Nov 1993
SR SPECTRASIT, SR CHROMASIT
K930128 · Ivoclar North America, Inc. · Oct 1993
ALPHA-DENT LIGHT ACTIVATED CORE BUILDUP BLUE PASTE
K932886 · Wallace A. Erickson & Co. · Sep 1993