Cleared Traditional

K012946 - SUNLITELED MODEL #2810

K012946 is an FDA 510(k) clearance for SUNLITELED MODEL #2810, manufactured by Kinetic Instruments, Inc.. The device is a Class 2 Dental device with product code EBZ cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K012946 · Kinetic Instruments, Inc. · Dental device
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Oct 2001
Decision
28d
Days
Class 2
Risk

K012946 is an FDA 510(k) clearance for the SUNLITELED MODEL #2810. Classified as Activator, Ultraviolet, For Polymerization (product code EBZ), Class II - Special Controls.

Submitted by Kinetic Instruments, Inc. (Bethel, US). The FDA issued a Cleared decision on October 2, 2001 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 Kinetic Instruments, Inc. devices

FDA 510(k) Submission Details - K012946

510(k) Number K012946 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 2001
Decision Date October 02, 2001
Days to Decision 28 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
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.

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 129
Devices cleared under the same product code (EBZ) and FDA review panel - the closest regulatory comparables to K012946.
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GC E-LIGHT
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ELIPAR FREELIGHT
K011154 · Espe Dental AG · May 2001