Cleared Traditional

K102561 - ORTHODONTIC CERAMIC BRACKET

K102561 is an FDA 510(k) clearance for ORTHODONTIC CERAMIC BRACKET, manufactured by Ht Co., Ltd.. The device is a Class 2 Dental device with product code NJM cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K102561 · Ht Co., Ltd. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2011
Decision
140d
Days
Class 2
Risk

K102561 is an FDA 510(k) clearance for the ORTHODONTIC CERAMIC BRACKET. Classified as Bracket, Ceramic, Orthodontic (product code NJM), Class II - Special Controls.

Submitted by Ht Co., Ltd. (Ansan-Si, Gyeonggi-Do, KR). The FDA issued a Cleared decision on January 25, 2011 after a review of 140 days - within the typical 510(k) review window.

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.

FDA 510(k) Submission Details - K102561

510(k) Number K102561 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 2010
Decision Date January 25, 2011
Days to Decision 140 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
12d slower than avg
Panel avg: 128d · This submission: 140d
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 Peers - NJM Bracket, Ceramic, Orthodontic

All 59
Devices cleared under the same product code (NJM) and FDA review panel - the closest regulatory comparables to K102561.
CERAMIC BRACKETS
K110335 · Ortho Organizers, Inc. · May 2011
CLICK-IT
K111234 · Tp Orthodontics, Inc. · May 2011
CLARITY ADVANCED CERAMIC BRACKETS
K102803 · 3M Unitek Corporation · Feb 2011
BIOMERS TRANSLUCENT ORTHODONTIC BRACKET
K101481 · Biomers Products, LLC · Jun 2010
CDB FLIP-SIDE-CLIP BRACKET
K091702 · Cdb Corporation · Aug 2009
BERNHARD-FORSTER GMBH ORTHODONTIC CERAMIC BRACKETS
K090933 · Forestadent Bernhard Forster GmbH · Jun 2009
K102561 · ORTHODONTIC CERAMIC BRACKET
Download PDF FDA Summary Ht Co., Ltd.