510(k) · Cleared
ClearedDio-Dent 10 Dental Diode Laser
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Msq (M2), Ltd. · GEX Powered Laser Surgical Instrument
Cleared on Oct 30, 2003 as substantially equivalent to K983058 (Ceram Optec, Inc., 1998) and 6 other predicates after a 140-day review. Its family tree reaches back 4 generations to 1992.
- Decided
- Oct 30, 2003
- Review
- 140 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 4 generations to K922901 (1992). 15 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK922901 Incisor I Pulsed ND:Yag Laser SystemBuckman Co., Inc. · 1992
- 3 generations backK972325 Pulsemaster 1000 ST Dental Laser SystemAmerican Dental Technologies, Inc. · 1997
- 2 generations backK983058 Ceralas D Laser System, Model # Ceralas D15Ceram Optec, Inc. · 1998
- 1 generation backK991891 Ceralas Diode Laser System, Model Ceralas D15Ceram Optec, Inc. · 1999
- This deviceK031819 Dio-Dent 10 Dental Diode LaserMsq (M2), Ltd. · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K922901 | Incisor I Pulsed ND:Yag Laser System | Buckman Co., Inc. | 1992 | — |
| −3 | K972325 | Pulsemaster 1000 ST Dental Laser System | American Dental Technologies, Inc. | 1997 | — |
| −2 | K983058 | Ceralas D Laser System, Model # Ceralas D15 | Ceram Optec, Inc. | 1998 | — |
| −1 | K991891 | Ceralas Diode Laser System, Model Ceralas D15 | Ceram Optec, Inc. | 1999 | — |
| 0 (this device) | K031819 | Dio-Dent 10 Dental Diode Laser | Msq (M2), Ltd. | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
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
What was it cleared against? (7)
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 | Decided |
|---|---|---|---|
| * | K983058 | Ceralas D Laser System, Model # Ceralas D15Summary page 1…Laser System substantially equivalent to the Ceralase D 9 8 0 m Diode Laser System, Model D I5 (Ceramoptec, Inc.) cleared under K983058, K99 I S9 1, K993002, K993911 and KO22351 in terms of technological characteristics, pe… | 1998 |
| * | K991891 | Ceralas Diode Laser System, Model Ceralas D15 Our reading of the summary gave K991591, FDA’s number for Biothane Patient Restraint (Bioplastics). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Ceralase D980m Diode Laser System, Model D15”. | 1999 |
| * | K993002 | Ceralas D 980NM Diode Laser System, Model D15Summary page 1…equivalent to the Ceralase D 9 8 0 m Diode Laser System, Model D I5 (Ceramoptec, Inc.) cleared under K983058, K99 I S9 1, K993002, K993911 and KO22351 in terms of technological characteristics, performance, intended use, indications for u… | 1999 |
| * | K993911 | Ceralas D Diode Laser System, Model D15, D25,D50Summary page 1…ivalent to the Ceralase D 9 8 0 m Diode Laser System, Model D I5 (Ceramoptec, Inc.) cleared under K983058, K99 I S9 1, K993002, K993911 and KO22351 in terms of technological characteristics, performance, intended use, indications for use and… | 2000 |
| * | K022351 | Diodent Dental Laser System | 2002 |
| * | K000990 | Opus 10 Dental Diode Laser | 2000 |
| * | K011769 | Opus 10 (with Tooth Whitening Application), Model 2ND | 2001 |
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 11 years and passes through 4 companies; a new generation was cleared every 4.4 years on median.
- None of the 15 ancestors has a recall.
- 5 other devices also cite its predicate K983058.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GEX
83in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEX
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEX
3in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GEX
2,720in 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 Dio-Dent 10 Dental Diode Laser System is intended for incision, excision, ablation, vaporization and/or coagulation (hemostasis) of oral soft tissue (including marginal and interdental gingiva and epithelial lining of free gingiva). In addition, the system is intended for teeth whitening. The Indications for Use of the Dio-Dent 10 Dental Diode Laser System include: Cosmetic Dentistry Light activation for bleaching materials for teeth whitening…
Read the full statement (172 words)
The Dio-Dent 10 Dental Diode Laser System is intended for incision, excision, ablation, vaporization and/or coagulation (hemostasis) of oral soft tissue (including marginal and interdental gingiva and epithelial lining of free gingiva). In addition, the system is intended for teeth whitening.
The Indications for Use of the Dio-Dent 10 Dental Diode Laser System include:
Cosmetic Dentistry
Light activation for bleaching materials for teeth whitening, Laser-assisted bleaching/whitening of the teeth
Endodontology
Pulpotomy, Pulpotomy as an adjunct to root canal therapy
Periodontology
Sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket)
Oral Soft Tissue Surgery
Biopsy, Operculectomy, Gingivectomy, Gingivoplasty, Oral papillectomy, Leukoplakia, Treatment of aphthous ulcers, Fibroma removal, Frenectomy, Frenotomy, Tissue retraction for impressions, Incising and draining of abscesses, Draining fistulas, Exposure of unerupted partially erupted teeth, Lesion (tumor) removal, Implant recovery, Implant uncovering, Gingival troughing, Crown lengthening, Hemostasis of donor site, Coagulation and decontamination of extraction sites, Removal of granulation tissue, Degranulation of infrabony defects, Laser assisted flap surgery, Vestibuloplasty, Removal of hyperplastic tissues, Debridement of diseased epithelial lining
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031819 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031819: Dio-Dent 10 Dental 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/K031819
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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