Cleared Abbreviated

K153514 - Premium Plus C01/C02 LED Curing Light

K153514 is an FDA 510(k) clearance for Premium Plus C01/C02 LED Curing Light, manufactured by Premium Plus International Limited. The device is a Class 2 Dental device with product code EBZ cleared through the Abbreviated 510(k) pathway after a 259-day FDA review.

K153514 · Premium Plus International Limited · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2016
Decision
259d
Days
Class 2
Risk

K153514 is an FDA 510(k) clearance for the Premium Plus C01/C02 LED Curing Light. Classified as Activator, Ultraviolet, For Polymerization (product code EBZ), Class II - Special Controls.

Submitted by Premium Plus International Limited (Hong Kong, CN). The FDA issued a Cleared decision on August 22, 2016 after a review of 259 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Premium Plus International Limited devices

FDA 510(k) Submission Details - K153514

510(k) Number K153514 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 2015
Decision Date August 22, 2016
Days to Decision 259 days
Submission Type Abbreviated
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
132d slower than avg
Panel avg: 127d · This submission: 259d
Pathway characteristics
Standards-based clearance path.

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 98
Devices cleared under the same product code (EBZ) and FDA review panel - the closest regulatory comparables to K153514.
Cybird LED Curing Light
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