Cleared Traditional

K000426 - VIP- VARIABLE INTENSITY POLYMERIZER

K000426 is an FDA 510(k) clearance for VIP- VARIABLE INTENSITY POLYMERIZER, manufactured by Bisco, Inc.. The device is a Class 2 Dental device with product code EBZ cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K000426 · Bisco, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2000
Decision
63d
Days
Class 2
Risk

K000426 is an FDA 510(k) clearance for the VIP- VARIABLE INTENSITY POLYMERIZER. Classified as Activator, Ultraviolet, For Polymerization (product code EBZ), Class II - Special Controls.

Submitted by Bisco, Inc. (Schaumburg, US). The FDA issued a Cleared decision on April 12, 2000 after a review of 63 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6070 - 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.

FDA 510(k) Submission Details - K000426

510(k) Number K000426 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 09, 2000
Decision Date April 12, 2000
Days to Decision 63 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
65d faster than avg
Panel avg: 128d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBZ Device Classification - Class 2, Special Controls

Product Code EBZ Activator, Ultraviolet, For Polymerization
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.6070
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 - EBZ Activator, Ultraviolet, For Polymerization

All 213
Devices cleared under the same product code (EBZ) and FDA review panel - the closest regulatory comparables to K000426.
LUMALITE CURE LIGHT, MODEL 2100
K002566 · Lumalite, Inc. · Oct 2000
Q-LUX PLASMA 100 LIGHT CURE UNIT
K001719 · Rolence Enterprise Co. , Ltd. · Oct 2000
JETLITE 4000
K000078 · J. Morita USA, Inc. · May 2000
NOVA CORDLESS CURING LIGHT
K000393 · Nova/Da Vinci Systems, Inc. · Mar 2000
PORTABLE LIGHT CURING UNIT
K994048 · Gregory S. Jacob, D.D.S. · Jan 2000
FLIPO XENON CURING LIGHT
K994028 · Lokki · Jan 2000
K000426 · VIP- VARIABLE INTENSITY POLYMERIZER
Download PDF FDA Summary Bisco, Inc.