510(k) · Cleared

Cleared

Diodent Micro Dental Laser System, Models 810 and 980

K063384510(k) TraditionalCleared Mar 16, 2007128-day reviewClass II21 CFR 878.4810

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

Hoya Conbio, Inc. · GEX Powered Laser Surgical Instrument

Cleared on Mar 16, 2007 as substantially equivalent to K053161 (Sirona Dental Systems GmbH, 2006) and 2 other predicates after a 128-day review. Its family tree reaches back 5 generations to 1992. 13 later devices descend from it.

Decided: Mar 16, 2007
Review: 128 days
Class: Class II
Product code: GEX
Recalls: None
Predicates: 3

Its longest line of descent runs back 5 generations to K922901 (1992). 15 ancestors in all. 13 later devices descend from it, 5 citing it directly.

By dateBy generation

Root · 5 generations backK922901 Incisor I Pulsed ND:Yag Laser SystemBuckman Co., Inc. · 1992
4 generations backK972325 Pulsemaster 1000 ST Dental Laser SystemAmerican Dental Technologies, Inc. · 1997
3 generations backK983058 Ceralas D Laser System, Model # Ceralas D15Ceram Optec, Inc. · 1998
2 generations backK991891 Ceralas Diode Laser System, Model Ceralas D15Ceram Optec, Inc. · 1999
1 generation backK053161 SirolaserSirona Dental Systems GmbH · 2006
This deviceK063384 Diodent Micro Dental Laser System, Models 810 and 980Hoya Conbio, Inc. · 2007
Descendant · cites it directly · 8 of its ownK100474 Quicklasedual+, QUICKLASE810, QUICKLASE810, QUICKLASE980…Quicklase Limited · 2010
Descendant · 2 generations on · 7 of its ownK152032 ELUMI 810 + 980 Soft Tissue LaserAzena Medical, LLC · 2015
Descendant · 2 generations on · 2 of its ownK193486 Epic 980Biolase, Inc. · 2020
Descendant · 3 generations on · 2 of its ownK192617 Gemini 810+980 Soft Tissue LaserAzena Medical, LLC · 2020
Descendant · 3 generations on · 1 of its ownK234085 LUNE™ PureHygieneEnamel Pure · 2024

Showing 5 of 13 descendants. See all descendants

Descendants cleared per year

2008high 2 (2008) · low 0 (2009)2026

Most influential descendants

Showing 5 of 13 · See all

K100474Quicklasedual+, QUICKLASE810, QUICKLASE810, QUICKLASE980, QUICKLASE980 Model: 3W,5W,3W,5WQuicklase Limited · 2010 · cites it directly8descendants
K152032ELUMI 810 + 980 Soft Tissue LaserAzena Medical, LLC · 2015 · 2 generations on7descendants
K193486Epic 980Biolase, Inc. · 2020 · 2 generations on2descendants
K192617Gemini 810+980 Soft Tissue LaserAzena Medical, LLC · 2020 · 3 generations on2descendants
K234085LUNE™ PureHygieneEnamel Pure · 2024 · 3 generations on1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−5	K922901	Incisor I Pulsed ND:Yag Laser System	Buckman Co., Inc.	1992	—
−4	K972325	Pulsemaster 1000 ST Dental Laser System	American Dental Technologies, Inc.	1997	—
−3	K983058	Ceralas D Laser System, Model # Ceralas D15	Ceram Optec, Inc.	1998	—
−2	K991891	Ceralas Diode Laser System, Model Ceralas D15	Ceram Optec, Inc.	1999	—
−1	K053161	Sirolaser	Sirona Dental Systems GmbH	2006	—
0 (this device)	K063384	Diodent Micro Dental Laser System, Models 810 and 980	Hoya Conbio, Inc.	2007	—
+1	K100474	Quicklasedual+, QUICKLASE810, QUICKLASE810, QUICKLASE980, QUICKLASE980 Model…	Quicklase Limited	2010	—
+2	K152032	ELUMI 810 + 980 Soft Tissue Laser	Azena Medical, LLC	2015	—
+2	K193486	Epic 980	Biolase, Inc.	2020	—
+3	K192617	Gemini 810+980 Soft Tissue Laser	Azena Medical, LLC	2020	—
+3	K234085	LUNE™ PureHygiene	Enamel Pure	2024	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1995	2	0
1996	1	0
1997	2	0
1998	3	0
1999	1	0
2005	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2008	2	0
2010	2	0
2015	1	0
2017	1	0
2020	2	0
2021	1	0
2023	1	0
2024	1	0
2026	2	0

FIG. 1 — Lineage of K063384, 1992–2026Source: 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 GEX? 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 GEX device

#1 K222064 The Alma Soprano Titaniumscore 38.1 · 24 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (3)

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
*	K053161	Sirolaser Summary page 1 …intended to destroy or coagulate tissue by light energy emitted by argon. Equivalent Device: SIROLaser by Shrona Dental Systems, K053161 DioDent II Dental Laser System by HOYA Con~io, K050274 Twilight Diode Laser Sys…	Sirona Dental Systems GmbH	2006	—
*	K050274	Diodent II Dental Laser System Summary page 1 …argon. Equivalent Device: SIROLaser by Shrona Dental Systems, K053161 DioDent II Dental Laser System by HOYA Con~io, K050274 Twilight Diode Laser System by BioLase Technologies, K99 1994 Device Description: The laser sourc…	Hoya Photonics, Inc.	2005	—
*	K991994	Twilight Summary page 1 …ms, K053161 DioDent II Dental Laser System by HOYA Con~io, K050274 Twilight Diode Laser System by BioLase Technologies, K99 1994 Device Description: The laser sourc of the DioDent Micro 8 10/980 is a solid-state Gallium Aluminu…	Biolase Technology, Inc.	1999	—

Also cleared against K053161: 7 other devices →

What descends from it? (13)

See all 13

5 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K100474	Quicklasedual+, QUICKLASE810, QUICKLASE810, QUICKLASE980, QUICKLASE980 Model: 3W,5W,3W,5W	Quicklase Limited	2010	8
K163638	Dental 5 Multi Diode laser	Bio-Med USA, Inc.	2017	0
K093048	D-Storm 810NM, D-Storm 980NM	Light Instruments	2010	0
K082445	CURATIVE980 Diode Laser	Oroscience, Inc.	2008	0
K073332	V-Raser Diode Laser System	Hoya Conbio, Inc.	2008	0

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 15 years and passes through 5 companies; a new generation was cleared every 1.2 years on median.
None of the 15 ancestors has a recall.
Of its descendants, K100474 (Quicklase Limited, 2010) has gone furthest, with 8 descendants of its own.
7 other devices also cite its predicate K053161.

How does its category compare?

All GEX devices

GEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · GEX

83in 2025

2007high 107 (2008) · low 41 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GEX

90in 2025

2007high 152 (2022) · low 78 (2018)2026

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

Recalls per year · GEX

3in 2024

2007high 18 (2011) · low 0 (2009)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · GEX

2,720in 2025

2007high 3,525 (2018) · low 209 (2009)2025

MAUDE reports naming product code GEX, 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	73	79	9	342
2008	107	86	2	232
2009	69	100	0	209
2010	50	96	4	1,711
2011	41	83	18	3,024
2012	45	118	5	2,000
2013	46	144	3	2,236
2014	61	147	6	2,036
2015	47	112	0	2,099
2016	51	114	1	2,585
2017	67	90	5 (1)	2,977
2018	51	78	5	3,525
2019	41	88	6	2,709
2020	52	90	1	2,183
2021	53	123	0	3,465
2022	60	152	0	2,288
2023	52	87	6	2,337
2024	82	90	3	2,187
2025	83	90	0	2,720
2026	57	90	2	—

What is it indicated for?

For the incision, excision, ablation, vaporization, and hemostasis of oral soft tissue. Examples: Excisional and incisional biopsies Exposure of unerupted teeth Fibroma removal Frenectomy and frenotomy Gingival troughing for crown impressions Gingivectomy Gingivoplasty Gingival incision and excision Hemostasis Implant recovery Incision and drainage of abscess Leukoplakia Operculectomy Oral papillectomies Pulpotomy Pulpotomy as an adjunct to root canal…

Read the full statement (129 words)

For the incision, excision, ablation, vaporization, and hemostasis of oral soft tissue.

Examples: Excisional and incisional biopsies

Exposure of unerupted teeth

Fibroma removal

Frenectomy and frenotomy

Gingival troughing for crown impressions

Gingivectomy

Gingivoplasty

Gingival incision and excision

Hemostasis

Implant recovery

Incision and drainage of abscess

Leukoplakia

Operculectomy

Oral papillectomies

Pulpotomy

Pulpotomy as an adjunct to root canal therapy

Reduction of gingival hypertrophy

Reduction of bacterial level (decontamination) and inflammation

Soft tissue crown lengthening

Sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility)

Treatment of aphthous ulcers

Vestibuloplasty

Biopsy incision and excision

Lesion (tumor) removal

For light activation for bleaching materials for teeth whitening

For laser-assisted bleaching/whitening for teeth.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K063384 · printed Nov 4, 2026

Cite this page

510(k) Report. “K063384: Diodent Micro Dental Laser System, Models 810 and 980.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063384

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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