510(k) · Cleared
ClearedDental diode laser
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Soga Technology Co., Ltd. · NVK Laser, Dental, Soft Tissue
Cleared on May 10, 2022 as substantially equivalent to K103753 (Sirona Dental Systems GmbH, 2011) after a 139-day review. Its family tree reaches back 8 generations to 1992.
- Decided
- May 10, 2022
- Review
- 139 days
- Class
- Class II
- Product code
- NVK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K922901 (1992). 23 ancestors in all. No later device cites it as a predicate yet.
- Root · 8 generations backK922901 Incisor I Pulsed ND:Yag Laser SystemBuckman Co., Inc. · 1992
- 7 generations backK972325 Pulsemaster 1000 ST Dental Laser SystemAmerican Dental Technologies, Inc. · 1997
- 6 generations backK983058 Ceralas D Laser System, Model # Ceralas D15Ceram Optec, Inc. · 1998
- 5 generations backK991891 Ceralas Diode Laser System, Model Ceralas D15Ceram Optec, Inc. · 1999
- 4 generations backK053161 SirolaserSirona Dental Systems GmbH · 2006
- 3 generations backK062258 Genesis Diode LaserIvoclar Vivadent, Inc. · 2007
- 2 generations backK092660 Sirolaser AdvanceSirona Dental Systems GmbH · 2009
- 1 generation backK103753 Sirolaser Advance, Sirolaser Xtend, Sirolaser Xtend Upgraded…Sirona Dental Systems GmbH · 2011
- This deviceK214008 Dental diode laserShenzhen Soga Technology Co., Ltd. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K922901 | Incisor I Pulsed ND:Yag Laser System | Buckman Co., Inc. | 1992 | — |
| −7 | K972325 | Pulsemaster 1000 ST Dental Laser System | American Dental Technologies, Inc. | 1997 | — |
| −6 | K983058 | Ceralas D Laser System, Model # Ceralas D15 | Ceram Optec, Inc. | 1998 | — |
| −5 | K991891 | Ceralas Diode Laser System, Model Ceralas D15 | Ceram Optec, Inc. | 1999 | — |
| −4 | K053161 | Sirolaser | Sirona Dental Systems GmbH | 2006 | — |
| −3 | K062258 | Genesis Diode Laser | Ivoclar Vivadent, Inc. | 2007 | — |
| −2 | K092660 | Sirolaser Advance | Sirona Dental Systems GmbH | 2009 | — |
| −1 | K103753 | Sirolaser Advance, Sirolaser Xtend, Sirolaser Xtend Upgraded, Fonalaser | Sirona Dental Systems GmbH | 2011 | — |
| 0 (this device) | K214008 | Dental diode laser | Shenzhen Soga Technology Co., Ltd. | 2022 | — |
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 | 1 | 0 |
| 2001 | 2 | 0 |
| 2003 | 2 | 0 |
| 2005 | 1 | 0 |
| 2007 | 2 | 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 NVK? 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 NVK device
- #1 K210367 D-Laser Blue, D-Laser 16score 20.7 · 20 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K103753 | Sirolaser Advance, Sirolaser Xtend, Sirolaser Xtend Upgraded, FonalaserSummary page 4…lass II 5.3 Predicate Device Information Predicate Device: SIROLaser Advance (Model: FonaLaser) Manufacturer: Sirona Dental Systems GmbH 510(k) number: K103753 Indication of use: Intra- and extra-oral surgery including incision, excision, hemostasis, coagulation and vapori… | 2011 |
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 30 years and passes through 6 companies; a new generation was cleared every 2.7 years on median.
- 1 of the 23 ancestors has a recall of any class.
- 3 other devices also cite its predicate K103753.
How does its category compare?
All NVK devicesNVK Laser, Dental, Soft Tissue: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · NVK
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NVK
139in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NVK
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NVK
1in 2024
MAUDE reports naming product code NVK, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 1 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 4 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 4 | 277 | 0 | 0 |
| 2022 | 5 | 139 | 0 | 0 |
| 2023 | 1 | — | 1 | 0 |
| 2024 | 2 | — | 0 | 1 |
| 2025 | 2 | — | 0 | 0 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
Intra- and extra-oral surgery including incision, excision, hemostasis, coagulation and vaporization of soft tissue; marginal and interdental gingival and epithelial lining of free gingiva; frenectomy; frenotomy; biopsy; operculectomy; Implant recovery; gingivectomy; gingivoplasty; gingival troughing; crown lengthening; hemostasis of donor site; removal of granulation tissue; laser assisted flap surgery; debridement of deseased epithelial lining…
Read the full statement (161 words)
Intra- and extra-oral surgery including incision, excision, hemostasis, coagulation and vaporization of soft tissue; marginal and interdental gingival and epithelial lining of free gingiva; frenectomy; frenotomy; biopsy; operculectomy; Implant recovery; gingivectomy; gingivoplasty; gingival troughing; crown lengthening; hemostasis of donor site; removal of granulation tissue; laser assisted flap surgery; debridement of deseased epithelial lining ; incisions and draining of abscesses; tissue retraction for impressions; papillectomy; vestibuloplasty; excision of lesions ; exposure of unerupted/partially erupted teeth; removal of hyperplastic tissues; treatment of aphthous ulcers; leukoplakia; Laser removal of diseased, infected, inflamed and necrosed soft tissue within the periodontal pocket; Sulcular debridement (removal of diseased, infected, inflamed and necrosed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth inability); pulpotomy; pulpotomy as adjunct to root canal therapy; Fibroma removal; Gingival incision and excision; Treatment of canker sores; herpetic ulcers of the oral mucosa; Laser soft tissue curettage; Reduction of gingival hypertrophy;.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K214008 · printed Nov 4, 2026
Cite this page
510(k) Report. “K214008: Dental diode laser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K214008
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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