Cleared Traditional

K152936 - Sirius Max Dental Diode Curing Light

K152936 is an FDA 510(k) clearance for Sirius Max Dental Diode Curing Light, manufactured by National Dental, Inc.. The device is a Class 2 Dental device with product code EBZ cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K152936 · National Dental, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2015
Decision
39d
Days
Class 2
Risk

K152936 is an FDA 510(k) clearance for the Sirius Max Dental Diode Curing Light. Classified as Activator, Ultraviolet, For Polymerization (product code EBZ), Class II - Special Controls.

Submitted by National Dental, Inc. (Barrie, CA). The FDA issued a Cleared decision on November 13, 2015 after a review of 39 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.

FDA 510(k) Submission Details - K152936

510(k) Number K152936 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 05, 2015
Decision Date November 13, 2015
Days to Decision 39 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
89d faster than avg
Panel avg: 128d · This submission: 39d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Regulatory Technology Services, LLC
MARK JOB

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - EBZ Activator, Ultraviolet, For Polymerization

All 195
Devices cleared under the same product code (EBZ) and FDA review panel - the closest regulatory comparables to K152936.
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K140432 · Dentall Corporation · Aug 2015
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K133040 · Monitex Industrial Co., Ltd. · Oct 2014