Cleared Traditional

Dr's Light2 (K173157) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K173157 · Good Doctors Co., Ltd. · Dental device
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May 2018
Decision
242d
Days
Class 2
Risk

K173157 is an FDA 510(k) clearance for the Dr's Light2. Classified as Activator, Ultraviolet, For Polymerization (product code EBZ), Class II - Special Controls.

Submitted by Good Doctors Co., Ltd. (Incheon, KR). The FDA issued a Cleared decision on May 29, 2018 after a review of 242 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 Good Doctors Co., Ltd. devices

Submission Details

510(k) Number K173157 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2017
Decision Date May 29, 2018
Days to Decision 242 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
115d slower than avg
Panel avg: 127d · This submission: 242d
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 Consultant

LK Consulting Group USA, Inc.
Priscilla Chung

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 42
Devices cleared under the same product code (EBZ) and FDA review panel - the closest regulatory comparables to K173157.
VALO Grand Corded
K190627 · Ultradent Products, Inc. · Apr 2019
FUSION Plus Curing Light
K180065 · Dentlight, Inc. · Apr 2019
Le'Pen
K181597 · Kmihh, Ltd. · Apr 2019
Cybird LED Curing Light
K173876 · Dxm Co., Ltd. · Jan 2018
CELALUX 3
K153018 · Voco GmbH · Jun 2016
G-LIGHT
K050059 · GC America, Inc. · Feb 2005