Cleared Traditional

K033585 - DIAPEX

K033585 is the FDA 510(k) clearance for DIAPEX by Bisco, Inc.. It is a Class 2 Dental device (product code KIF) cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K033585 · Bisco, Inc. · Dental device
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Jan 2004
Decision
64d
Days
Class 2
Risk

K033585 is an FDA 510(k) clearance for the DIAPEX. Classified as Resin, Root Canal Filling (product code KIF), Class II - Special Controls.

Submitted by Bisco, Inc. (Schaumburg, US). The FDA issued a Cleared decision on January 16, 2004 after a review of 64 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3820 - 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 K033585 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 2003
Decision Date January 16, 2004
Days to Decision 64 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 127d · This submission: 64d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KIF Resin, Root Canal Filling
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3820
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 - KIF Resin, Root Canal Filling

All 74
Devices cleared under the same product code (KIF) and FDA review panel - the closest regulatory comparables to K033585.
ENDOREZ OBTURATION KIT (WITH ACCELERATOR), MODEL 403, ENDOREZ ACCELERATOR (REFILL), MODEL 399
K071106 · Ultradent Products, Inc. · May 2007
CZ-S2000
K060946 · Parkell, Inc. · Jun 2006
ENDOREZ
K042756 · Ultradent Products, Inc. · Oct 2004
FIRST FILL R.C.S.
K011748 · Jeneric/Pentron, Inc. · Aug 2001
SEALAPEX 4
K010940 · Sybron Dental Specialties, Inc. · Jun 2001
ENDOREZ
K992097 · Ultradent Products, Inc. · Oct 1999