Cleared Traditional

K020057 - PALMLIGHT

K020057 is an FDA 510(k) clearance for PALMLIGHT, manufactured by CAO Group, Inc.. The device is a Class 2 Dental device with product code EBZ cleared through the Traditional 510(k) pathway after a 231-day FDA review.

K020057 · CAO Group, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2002
Decision
231d
Days
Class 2
Risk

K020057 is an FDA 510(k) clearance for the PALMLIGHT. Classified as Activator, Ultraviolet, For Polymerization (product code EBZ), Class II - Special Controls.

Submitted by CAO Group, Inc. (Sandy, US). The FDA issued a Cleared decision on August 27, 2002 after a review of 231 days - an extended review 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: 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.

FDA 510(k) Submission Details - K020057

510(k) Number K020057 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 08, 2002
Decision Date August 27, 2002
Days to Decision 231 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
103d slower than avg
Panel avg: 128d · This submission: 231d
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 K020057.
ULTRA-LITE 200E LIGHT CURE UNIT
K023545 · Rolence Ent., Inc. · Dec 2002
TRANSCURE, MODEL 2910
K022862 · Kinetic Instruments, Inc. · Oct 2002
LIGHT TIP
K022265 · Svenska Dental Instruments AB · Oct 2002
FLASH-LITE LED DENTAL CURING LIGHT
K022184 · Discus Dental, Inc. · Aug 2002
L.E.DEMETRON
K021797 · Sybron Dental Specialties, Inc. · Jun 2002
ULTRA-LITE 5 TURBO LIGHT CURE UNIT
K020874 · Rolence Ent., Inc. · Jun 2002
K020057 · PALMLIGHT
Download PDF FDA Summary CAO Group, Inc.