Cleared Traditional

K003383 - PALMLIGHT

K003383 is an FDA 510(k) clearance for PALMLIGHT, manufactured by Ultradent Products, Inc.. The device is a Class 2 Dental device with product code EBZ cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K003383 · Ultradent Products, Inc. · Dental device
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Feb 2001
Decision
98d
Days
Class 2
Risk

K003383 is an FDA 510(k) clearance for the PALMLIGHT. Classified as Activator, Ultraviolet, For Polymerization (product code EBZ), Class II - Special Controls.

Submitted by Ultradent Products, Inc. (South Jordan, US). The FDA issued a Cleared decision on February 6, 2001 after a review of 98 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Ultradent Products, Inc. devices

FDA 510(k) Submission Details - K003383

510(k) Number K003383 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 2000
Decision Date February 06, 2001
Days to Decision 98 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
29d faster than avg
Panel avg: 127d · This submission: 98d
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 140
Devices cleared under the same product code (EBZ) and FDA review panel - the closest regulatory comparables to K003383.
GC E-LIGHT
K012134 · GC America, Inc. · Aug 2001
ELIPAR FREELIGHT
K011154 · Espe Dental AG · May 2001
VERSALUX
K010133 · Centrix, Inc. · Apr 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