Cleared Traditional

K921439 - BISCO CORE PASTE

K921439 is the FDA 510(k) clearance for BISCO CORE PASTE by Bisco, Inc.. It is a Class 2 Dental device (product code EBF) cleared through the Traditional 510(k) pathway after a 47-day FDA review.

K921439 · Bisco, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1992
Decision
47d
Days
Class 2
Risk

K921439 is an FDA 510(k) clearance for the BISCO CORE PASTE. 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 May 11, 1992 after a review of 47 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 K921439 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 25, 1992
Decision Date May 11, 1992
Days to Decision 47 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
80d faster than avg
Panel avg: 127d · This submission: 47d
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 K921439.
COMPOSITE RESIN CORE PASTE MATERIAL
K921174 · Centrix, Inc. · Sep 1992
PULPDENT HARD CORE
K922755 · Pulpdent Corp. · Aug 1992
TETRIC LIGHT-CURING COMPOSITE
K922569 · Ivoclar North America, Inc. · Jul 1992
10% PHOSPHORIC ACID ETCHING GEL
K920483 · Pulpdent Corp. · Apr 1992
PUPLDENT ETCH N PREP
K920485 · Pulpdent Corp. · Apr 1992
14% HYDROFLUORIC ACID ETCHING GEL
K920482 · Pulpdent Corp. · Apr 1992