510(k) · Cleared
ClearedSpphine Plus STM 3W Diode Laser
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Den-Mat Holdings, LLC · GEX Powered Laser Surgical Instrument
Cleared on Feb 10, 2011 as substantially equivalent to K062258 (Ivoclar Vivadent, Inc., 2007) and 2 other predicates after a 30-day review. Its family tree reaches back 7 generations to 1992.
- Decided
- Feb 10, 2011
- Review
- 30 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K922901 (1992). 25 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK922901 Incisor I Pulsed ND:Yag Laser SystemBuckman Co., Inc. · 1992
- 6 generations backK972325 Pulsemaster 1000 ST Dental Laser SystemAmerican Dental Technologies, Inc. · 1997
- 5 generations backK983058 Ceralas D Laser System, Model # Ceralas D15Ceram Optec, Inc. · 1998
- 4 generations backK991891 Ceralas Diode Laser System, Model Ceralas D15Ceram Optec, Inc. · 1999
- 3 generations backK053161 SirolaserSirona Dental Systems GmbH · 2006
- 2 generations backK062258 Genesis Diode LaserIvoclar Vivadent, Inc. · 2007
- 1 generation backK081214 Styla Microlaser and StylaorthoZap Lasers, LLC · 2008
- This deviceK110079 Spphine Plus STM 3W Diode LaserDen-Mat Holdings, LLC · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K922901 | Incisor I Pulsed ND:Yag Laser System | Buckman Co., Inc. | 1992 | — |
| −6 | K972325 | Pulsemaster 1000 ST Dental Laser System | American Dental Technologies, Inc. | 1997 | — |
| −5 | K983058 | Ceralas D Laser System, Model # Ceralas D15 | Ceram Optec, Inc. | 1998 | — |
| −4 | K991891 | Ceralas Diode Laser System, Model Ceralas D15 | Ceram Optec, Inc. | 1999 | — |
| −3 | K053161 | Sirolaser | Sirona Dental Systems GmbH | 2006 | — |
| −2 | K062258 | Genesis Diode Laser | Ivoclar Vivadent, Inc. | 2007 | — |
| −1 | K081214 | Styla Microlaser and Stylaortho | Zap Lasers, LLC | 2008 | — |
| 0 (this device) | K110079 | Spphine Plus STM 3W Diode Laser | Den-Mat Holdings, LLC | 2011 | — |
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 | 4 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2007 | 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? (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 | Decided |
|---|---|---|---|
| * | K062258 | Genesis Diode LaserSummary page 1…Laser instrument, surgical Product Code: GEX Predicate Device(s): Ivoclar Vivadent, Inc. Odyssey Navigator Diode Laser (K06225 8); Zap Lasers, LLC Styla MicroLaser/StylaOrtho Laser (K08 1214); Ivoclar Vivadent, Inc. Odyssey 2.4G… | 2007 |
| * | K081214 | Styla Microlaser and StylaorthoSummary page 1…oclar Vivadent, Inc. Odyssey Navigator Diode Laser (K06225 8); Zap Lasers, LLC Styla MicroLaser/StylaOrtho Laser (K08 1214); Ivoclar Vivadent, Inc. Odyssey 2.4G (K050453) Rationale for Substantial Equivalence Both the subj… | 2008 |
| * | K050453 | Odyssey 2.4G, Denlaser Elite, Model 002-00050Summary page 1…(K06225 8); Zap Lasers, LLC Styla MicroLaser/StylaOrtho Laser (K08 1214); Ivoclar Vivadent, Inc. Odyssey 2.4G (K050453) Rationale for Substantial Equivalence Both the subject and predicate laser devices share similar intended uses and indications… | 2005 |
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 19 years and passes through 7 companies; a new generation was cleared every 1.2 years on median.
- 1 of the 25 ancestors has a recall of any class.
- 9 other devices also cite its predicate K062258.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
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 Sapphire Plus SIM 3W Diode Laser is intended for use in dental intraoral soft tissue general, oral maxilla-facial and cosmetic surgery. It is intended for ablating, incising, excising, vaporizing and coagulation of soft tissues using a fibre optic delivery system. Indications include excision and incision biopsies; hemostatic assistance; treatment of apthous ulcers; frenectomy; frenotomy; gingival incision and excision; gingivectomy; gingivoplasty…
Read the full statement (94 words)
The Sapphire Plus SIM 3W Diode Laser is intended for use in dental intraoral soft tissue general, oral maxilla-facial and cosmetic surgery. It is intended for ablating, incising, excising, vaporizing and coagulation of soft tissues using a fibre optic delivery system. Indications include excision and incision biopsies; hemostatic assistance; treatment of apthous ulcers; frenectomy; frenotomy; gingival incision and excision; gingivectomy; gingivoplasty; incising and draining abscesses; operculectomy; oral papilleetomy; removal of fibromas; soft tissue crown lengthening; sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket); tissue retraction for impression; and vestibuloplasty.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110079 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110079: Spphine Plus STM 3W 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/K110079
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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