Cleared Traditional

K061341 - PALMLIGHT 10

K061341 is the FDA 510(k) clearance for PALMLIGHT 10 by CAO Group, Inc.. It is a Class 2 Dental device (product code EBZ) cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K061341 · CAO Group, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2006
Decision
28d
Days
Class 2
Risk

K061341 is an FDA 510(k) clearance for the PALMLIGHT 10, MODEL 001-00030. 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 June 12, 2006 after a review of 28 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 CAO Group, Inc. devices

Submission Details

510(k) Number K061341 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 2006
Decision Date June 12, 2006
Days to Decision 28 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
99d faster than avg
Panel avg: 127d · This submission: 28d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 65
Devices cleared under the same product code (EBZ) and FDA review panel - the closest regulatory comparables to K061341.
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