510(k) · Cleared

Cleared

Dentec LD 15 Diode Laser

K990680510(k) TraditionalCleared Jul 30, 1999150-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

Dentek Lasersystems Produktions Ges.M.B.H. · GEX Powered Laser Surgical Instrument

Cleared on Jul 30, 1999 after a 150-day review. FDA’s file for it is a 510(k) statement, which names no predicate.

Decided: Jul 30, 1999
Review: 150 days
Class: Class II
Product code: GEX
Recalls: None
Predicates: 0

FDA’s file for it is a 510(k) statement, which names no predicate.

FIG. 1 — Lineage of K990680Source: FDA 510(k) database · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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

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What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

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.

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.

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?

The DENTEK LD 15 LaserSystem is intended for use for incision, excision, vaporization, ablation, coagulation in oral soft tissue, for removal of diseased or inflamed soft tissue in the periodontal pocket and to perform pulpotomy and pulpotomy as adjunct to root canal therapy. - Endodontology / Pulpotomy and pulpotomy as adjunct to rootcanal therapy - Periodontology / Removal of diseased or inflamed soft tissue in the periodontal pocket ( sulcular…

Read the full statement (102 words)

The DENTEK LD 15 LaserSystem is intended for use for incision,

excision, vaporization, ablation, coagulation in oral soft tissue, for

removal of diseased or inflamed soft tissue in the periodontal pocket

and to perform pulpotomy and pulpotomy as adjunct to root canal therapy.

- Endodontology / Pulpotomy and pulpotomy as adjunct to rootcanal therapy

- Periodontology / Removal of diseased or inflamed soft tissue in the periodontal

pocket ( sulcular debridement )

~ Soft Tissue

Gingivectomy, Gingival incision and excisionTissue retraction for impressions,

Frenectomy, Treatment of aphtous ulcers, Excisional and incisional biopsies,

Incising and draining of abscesses, Exposure of unerupted teeth, Hemostasis

Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K990680 · printed Nov 6, 2026

Cite this page

510(k) Report. “K990680: Dentec LD 15 Diode Laser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K990680

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Record history

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