Cleared Traditional

K061695 - LED PROLUX 770

K061695 is an FDA 510(k) clearance for LED PROLUX 770, manufactured by Peng Lim Enterprise Co., Ltd.. The device is a Class 2 Dental device with product code EBZ cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K061695 · Peng Lim Enterprise Co., Ltd. · Dental device
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Sep 2006
Decision
91d
Days
Class 2
Risk

K061695 is an FDA 510(k) clearance for the LED PROLUX 770. Classified as Activator, Ultraviolet, For Polymerization (product code EBZ), Class II - Special Controls.

Submitted by Peng Lim Enterprise Co., Ltd. (Kaohsiung, TW). The FDA issued a Cleared decision on September 14, 2006 after a review of 91 days - within the typical 510(k) review window.

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.

View all Peng Lim Enterprise Co., Ltd. devices

FDA 510(k) Submission Details - K061695

510(k) Number K061695 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 2006
Decision Date September 14, 2006
Days to Decision 91 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
36d faster than avg
Panel avg: 127d · This submission: 91d
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 121
Devices cleared under the same product code (EBZ) and FDA review panel - the closest regulatory comparables to K061695.
DEMI
K071251 · Kerr Corporation · Jul 2007
PENCURE, MODEL VL-7
K063529 · J. Morita USA, Inc. · Jan 2007
AURORA
K063003 · Parkell, Inc. · Nov 2006
PALMLIGHT 10, MODEL 001-00030
K061341 · CAO Group, Inc. · Jun 2006
BISCO LED
K052122 · Bisco, Inc. · Mar 2006
BLUEPHASE 16I
K051782 · Ivoclar Vivadent, Inc. · Sep 2005