510(k) · Cleared

Cleared

Orthodontic Ceramic Bracket

K102561510(k) TraditionalCleared Jan 25, 2011140-day reviewClass II21 CFR 872.5470

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Ht Co., Ltd. · NJM Bracket, Ceramic, Orthodontic

Cleared on Jan 25, 2011 as substantially equivalent to K090567 (Star Dentech Korea., Corp, 2009) and 1 other predicate after a 140-day review. Its family tree reaches back 2 generations to 2007.

Decided: Jan 25, 2011
Review: 140 days
Class: Class II
Product code: NJM
Recalls: None
Predicates: 2

Its longest line of descent runs back 2 generations to K073045 (2007). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK073045 Sapphire Ceramic BracketOrtho Technology, Inc. · 2007
1 generation backK090567 Orthodontic Ceramic BracketStar Dentech Korea., Corp · 2009
This deviceK102561 Orthodontic Ceramic BracketHt Co., Ltd. · 2011

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K073045	Sapphire Ceramic Bracket	Ortho Technology, Inc.	2007	—
−1	K090567	Orthodontic Ceramic Bracket	Star Dentech Korea., Corp	2009	—
0 (this device)	K102561	Orthodontic Ceramic Bracket	Ht Co., Ltd.	2011	—

FIG. 1 — Lineage of K102561, 2007–2011Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in NJM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new NJM device

#1 K222764 LightForce Orthodontic Systemscore 8.5 · 6 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (2)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K090567	Orthodontic Ceramic Bracket Summary page 1 …ch Korea, Corp. and the Pure bracket from Ortho Technology. The Absolute bracket was most recently cleared by the FDA on May 27, 2009 under 5 10(k) K090567. The Pure bracket was cleared by the FDA on December 18, 2007 under 5 10(k) K073045. IV. Indications for use s…	Star Dentech Korea., Corp	2009	—
*	K073045	Sapphire Ceramic Bracket Summary page 1 …most recently cleared by the FDA on May 27, 2009 under 5 10(k) K090567. The Pure bracket was cleared by the FDA on December 18, 2007 under 5 10(k) K073045. IV. Indications for use statement MISO Translucent Orthodontic Bracket is indicated for orthodontic movement…	Ortho Technology, Inc.	2007	—

Also cleared against K090567: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 4 years and passes through 3 companies; a new generation was cleared every 1.7 years on median.
None of the 2 ancestors has a recall.
1 other device also cites its predicate K090567.

How does its category compare?

All NJM devices

NJM Bracket, Ceramic, Orthodontic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

FDA decisions per year · NJM

5in 2023

2007high 6 (2012) · low 0 (2024)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NJM

1in 2023

2007high 234 (2015) · low 1 (2023)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · NJM

1in 2013

2007high 1 (2013) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · NJM

1in 2025

2007high 6 (2013) · low 0 (2007)2025

MAUDE reports naming product code NJM, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	1	—	0	0
2008	4	134	0	0
2009	4	61	0	1
2010	1	—	0	2
2011	4	122	0	1
2012	6	90	0	1
2013	3	123	1	6
2014	1	—	0	0
2015	3	234	0	0
2016	3	176	0	2
2017	3	183	0	2
2018	4	76	0	2
2019	6	200	0	0
2020	2	—	0	1
2021	1	—	0	0
2022	2	—	0	0
2023	5	1	0	1
2024	0	—	0	2
2025	0	—	0	1
2026	0	—	0	—

What is it indicated for?

MISO Translucent Orthodontic Bracket is indicated for orthodontic movement of natural teeth, excluding mandibular bicuspid teeth.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K102561 · printed Nov 6, 2026

Cite this page

510(k) Report. “K102561: Orthodontic Ceramic Bracket.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102561

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026