Cleared Traditional

K201038 - Luce Ceramic Bracket

K201038 is an FDA 510(k) clearance for Luce Ceramic Bracket, manufactured by Luce Castle Co., Ltd.. The device is a Class 2 Dental device with 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

FDA 510(k) Submission Details - K201038

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.

NJM Device Classification - Class 2, Special Controls

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 45
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