Cleared Traditional

K940030 - BISCO COMPOSITE

K940030 is an FDA 510(k) clearance for BISCO COMPOSITE, manufactured by Bisco, Inc.. The device is a Class 2 Dental device with product code EMA cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K940030 · Bisco, Inc. · Dental device
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Feb 1994
Decision
32d
Days
Class 2
Risk

K940030 is an FDA 510(k) clearance for the BISCO COMPOSITE. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by Bisco, Inc. (Itasca, US). The FDA issued a Cleared decision on February 4, 1994 after a review of 32 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3275 - 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 - K940030

510(k) Number K940030 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 1994
Decision Date February 04, 1994
Days to Decision 32 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
95d faster than avg
Panel avg: 127d · This submission: 32d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EMA Device Classification - Class 2, Special Controls

Product Code EMA Cement, Dental
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3275
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 - EMA Cement, Dental

All 421
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K940030.
MULTIPURPOSE RESIN CEMENT WITH FLUORIDE (MRCF)
K940459 · Dentsply Intl. · Apr 1994
GRANITEC IONOMER RESIN CEMENT
K940546 · Confi-Dental Products Co. · Apr 1994
PANAVIA 21
K933030 · Kuraray Co. · Feb 1994
FLEXI-FLOW CEMENT NATURAL
K922249 · Essential Dental Systems, Inc. · Jan 1994
FLEXI-FLOW CEMENT WITH TITANIUM
K922250 · Essential Dental Systems, Inc. · Jan 1994
PRECEDENT
K934405 · Reliance Orthodontic Products, Inc. · Jan 1994