510(k) Report

510(k) · Cleared

Cleared

Cybird LED Curing Light

K173876510(k) SpecialCleared Jan 24, 201834-day reviewClass II21 CFR 872.6070

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

Dxm Co., Ltd. · EBZ Activator, Ultraviolet, For Polymerization

Cleared on Jan 24, 2018 as substantially equivalent to K121093 (Dxm Co., Ltd., 2012) after a 34-day review. Its family tree reaches back 4 generations to 1996. 1 later device descends from it.

Decided
Jan 24, 2018
Review
34 days
Class
Class II
Product code
EBZ
Recalls
None
Predicates
1

Its longest line of descent runs back 4 generations to K961735 (1996). 10 ancestors in all. 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2011: 1 other ancestor2004: 1 other ancestor2009: 1 other ancestor2001: 3 other ancestors2020: 1 descendant clearedReference device: K110428 · ESCOM 100 · Spident Co., Ltd. · 2011K961735 · ACTA · Satelec · 1996K032465 · Mini L.E.D., Model: Mini L.E.D., Model Smartlite Mini · Satelec · 2003K042703 · Cybird Led Curing Light · Dxm Co., Ltd. · 2004K121093 · D1 Led Curing Light, Spec 3, Dentronix Led 3000 · Dxm Co., Ltd. · 20121995200020052010201520202025
Other ancestors, by generationDescendants, by generation 2 generations back: 2 other ancestors3 generations back: 1 other ancestor4 generations back: 3 other ancestors 1 generation forward: 1 descendant K121093 · D1 Led Curing Light, Spec 3, Dentronix Led 3000 · Dxm Co., Ltd. · 2012K042703 · Cybird Led Curing Light · Dxm Co., Ltd. · 2004K032465 · Mini L.E.D., Model: Mini L.E.D., Model Smartlite Mini · Satelec · 2003K961735 · ACTA · Satelec · 19960
  1. Root · 4 generations backK961735 ACTASatelec · 1996
  2. 3 generations backK032465 Mini L.E.D., Model: Mini L.E.D., Model Smartlite MiniSatelec · 2003
  3. 2 generations backK042703 Cybird Led Curing LightDxm Co., Ltd. · 2004
  4. 1 generation backK121093 D1 Led Curing Light, Spec 3, Dentronix Led 3000Dxm Co., Ltd. · 2012
  5. This deviceK173876 Cybird LED Curing LightDxm Co., Ltd. · 2018
  6. Descendant · cites it directly · 0 of its ownK191221 Cybird LED Curing LightDxm Co., Ltd. · 2020

Most influential descendants

Showing 1 of 1 · See all
  • K191221Cybird LED Curing LightDxm Co., Ltd. · 2020 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K961735ACTASatelec1996—
−3K032465Mini L.E.D., Model: Mini L.E.D., Model Smartlite MiniSatelec2003—
−2K042703Cybird Led Curing LightDxm Co., Ltd.2004—
−1K121093D1 Led Curing Light, Spec 3, Dentronix Led 3000Dxm Co., Ltd.2012—
0 (this device)K173876Cybird LED Curing LightDxm Co., Ltd.2018—
+1K191221Cybird LED Curing LightDxm Co., Ltd.2020—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200130
200410
200910
201110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202010
FIG. 1 — Lineage of K173876, 1996–2020Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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 EBZ? 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 EBZ device

  1. #1 K253131 Curing Light (M-Cure 6)score 12.7 · 5 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (1)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K121093D1 Led Curing Light, Spec 3, Dentronix Led 3000
Summary page 5
…scriptive Device: Cybird LED Curing Light D1 LED Curing Light or SPEC3 or Information dental curing light LED 3000 (K121093) Intended Use The Cybird LED Curing Light is intended The D1 LED Curing Light & accessories to polymeri…
Dxm Co., Ltd.2012—
†K110428ESCOM 100Spident Co., Ltd.2011—

Also cleared against K121093: 1 other device →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K191221Cybird LED Curing LightDxm Co., Ltd.20200

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 22 years and passes through 2 companies; a new generation was cleared every 7.2 years on median.
  • None of the 10 ancestors has a recall.
  • Of its descendants, K191221 (Dxm Co., Ltd., 2020) has gone furthest, with 0 descendants of its own.
  • 1 other device also cites its predicate K121093.

How does its category compare?

All EBZ devices

EBZ Activator, Ultraviolet, For Polymerization: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.

FDA decisions per year · EBZ

4in 2025

2007: 102008: 52009: 42010: 12011: 32012: 12013: 32014: 32015: 42016: 42017: 82018: 22019: 52020: 52021: 12022: 52023: 32024: 12025: 42026 (partial year): 1
2007high 10 (2007) · low 1 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · EBZ

105in 2025

2007: 47 days median2008: 75 days median2009: 69 days median2011: 137 days median2013: 171 days median2014: 289 days median2015: 252 days median2016: 251 days median2017: 158 days median2019: 145 days median2020: 164 days median2022: 144 days median2023: 255 days median2025: 105 days median
2007high 289 (2014) · low 47 (2007)2026

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

Recalls per year · EBZ

1in 2022

2012: 12018: 12022: 1
2007high 1 (2012) · low 0 (2007)2026

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

Adverse event reports per year · EBZ

1in 2025

2007: 12008: 72009: 52010: 52011: 182012: 202013: 272014: 312015: 82016: 32017: 52018: 32020: 22021: 42022: 52023: 72024: 32025: 1
2007high 31 (2014) · low 0 (2019)2025

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

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007104701
200857507
200946905
20101—05
20113137018
20121—120
20133171027
20143289031
2015425208
2016425103
2017815805
20182—13
2019514500
2020516402
20211—04
2022514415
2023325507
20241—03
2025410501
20261—0—

What is it indicated for?

The Cybird LED Curing Light is intended to polymerize resinous dental materials, restorative composite materials and orthodontic brackets, bonding and sealing materials that are photo-polymerized in the 400-480 nm waveband of visible light.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K173876: Cybird LED Curing Light.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173876

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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