Cleared Traditional

K181597 - Le'Pen

K181597 is the FDA 510(k) clearance for Le'Pen by Kmihh, Ltd.. It is a Class 2 Dental device (product code EBZ) cleared through the Traditional 510(k) pathway after a 287-day FDA review.

K181597 · Kmihh, Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2019
Decision
287d
Days
Class 2
Risk

K181597 is an FDA 510(k) clearance for the Le'Pen. Classified as Activator, Ultraviolet, For Polymerization (product code EBZ), Class II - Special Controls.

Submitted by Kmihh, Ltd. (Kfar-Saba, IL). The FDA issued a Cleared decision on April 1, 2019 after a review of 287 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 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 Kmihh, Ltd. devices

Submission Details

510(k) Number K181597 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 2018
Decision Date April 01, 2019
Days to Decision 287 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
160d slower than avg
Panel avg: 127d · This submission: 287d
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 64
Devices cleared under the same product code (EBZ) and FDA review panel - the closest regulatory comparables to K181597.
Bluephase PowerCure
K190272 · Ivoclar Vivadent, AG · Jul 2019
VALO Grand Corded
K190627 · Ultradent Products, Inc. · Apr 2019
FUSION Plus Curing Light
K180065 · Dentlight, Inc. · Apr 2019
Dr's Light2
K173157 · Good Doctors Co., Ltd. · May 2018
Cybird LED Curing Light
K173876 · Dxm Co., Ltd. · Jan 2018
VALO Grand
K160551 · Ultradent Products, Inc. · Jul 2016