Cleared Traditional

K201038 - Luce Ceramic Bracket

K201038 is the FDA 510(k) clearance for Luce Ceramic Bracket by Luce Castle Co., Ltd.. It is a Class 2 Dental device (product code NJM) cleared through the Traditional 510(k) pathway after a 172-day FDA review.

K201038 · Luce Castle Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2020
Decision
172d
Days
Class 2
Risk

K201038 is an FDA 510(k) clearance for the Luce Ceramic Bracket. Classified as Bracket, Ceramic, Orthodontic (product code NJM), Class II - Special Controls.

Submitted by Luce Castle Co., Ltd. (Gyeonggi, KR). The FDA issued a Cleared decision on October 9, 2020 after a review of 172 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.5470 - 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 Luce Castle Co., Ltd. devices

Submission Details

510(k) Number K201038 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 2020
Decision Date October 09, 2020
Days to Decision 172 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
45d slower than avg
Panel avg: 127d · This submission: 172d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NJM Bracket, Ceramic, Orthodontic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.5470
Definition An Orthodontic Ceramic Bracket Is A Device Composed Of Ceramic, Which Is Intended To Be Bonded To A Tooth, Upon Which An Orthodontic Wire Is Used To Move The Tooth To A New Position.
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

Provision Consulting Group, Inc.
Joyce Bang-Kwon

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 - NJM Bracket, Ceramic, Orthodontic

All 24
Devices cleared under the same product code (NJM) and FDA review panel - the closest regulatory comparables to K201038.
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LightForce Orthodontic System (LFO System)
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Clear21
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