Cleared Traditional

K002991 - ZAP DUAL CURING LIGHT

K002991 is an FDA 510(k) clearance for ZAP DUAL CURING LIGHT, manufactured by Soft-Core Texas, Inc.. The device is a Class 2 Dental device with product code EBZ cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K002991 · Soft-Core Texas, Inc. · Dental device
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Nov 2000
Decision
64d
Days
Class 2
Risk

K002991 is an FDA 510(k) clearance for the ZAP DUAL CURING LIGHT. Classified as Activator, Ultraviolet, For Polymerization (product code EBZ), Class II - Special Controls.

Submitted by Soft-Core Texas, Inc. (North Richland Hills, US). The FDA issued a Cleared decision on November 28, 2000 after a review of 64 days - a notably fast clearance cycle.

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

View all Soft-Core Texas, Inc. devices

FDA 510(k) Submission Details - K002991

510(k) Number K002991 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 2000
Decision Date November 28, 2000
Days to Decision 64 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
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.

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 127
Devices cleared under the same product code (EBZ) and FDA review panel - the closest regulatory comparables to K002991.
VERSALUX
K010133 · Centrix, Inc. · Apr 2001
PALMLIGHT
K003383 · Ultradent Products, Inc. · Feb 2001
AVANTE CURELIGHT
K003683 · Jeneric/Pentron, Inc. · Jan 2001
JETLITE 4000
K000078 · J. Morita USA, Inc. · May 2000
VIP- VARIABLE INTENSITY POLYMERIZER
K000426 · Bisco, Inc. · Apr 2000
PORTABLE LIGHT CURING UNIT
K994048 · Gregory S. Jacob, D.D.S. · Jan 2000