510(k) · Cleared
ClearedModification of Millennium
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biolase Technology, Inc. · MXF System, Dental, Hydrokinetic, Caries Removal & Cavity Preparation
Cleared on Feb 24, 1999 after a 33-day review. The FDA summary names its predicate without a number. 247 later devices descend from it.
- Decided
- Feb 24, 1999
- Review
- 33 days
- Class
- Class II
- Product code
- MXF
- Recalls
- None
- Predicates
- 0
247 later devices descend from it, 1 citing it directly.
- This deviceK990219 Modification of MillenniumBiolase Technology, Inc. · 1999
- Descendant · cites it directly · 246 of its ownK012511 Waterlase MillenniumBiolase Technology, Inc. · 2002
- Descendant · 2 generations on · 240 of its ownK021508 Opusduo EC Dental Laser SystemOpusdent, Ltd. · 2002
- Descendant · 3 generations on · 226 of its ownK040270 Opusduo; Opusduo E; Opusduo EC; Opus 20; Opus SpectrumLumenis, Ltd. · 2004
- Descendant · 4 generations on · 221 of its ownK060033 Profile Multi-Platform SystemSciton, Inc · 2006
- Descendant · 5 generations on · 202 of its ownK073063 15W Ceralas D 1470NM Diode LaserBiolitec, Inc. · 2008
Showing 5 of 247 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 247 · See all- K012511Waterlase MillenniumBiolase Technology, Inc. · 2002 · cites it directly246descendants
- K021508Opusduo EC Dental Laser SystemOpusdent, Ltd. · 2002 · 2 generations on240descendants
- K040270Opusduo; Opusduo E; Opusduo EC; Opus 20; Opus SpectrumLumenis, Ltd. · 2004 · 3 generations on226descendants
- K060033Profile Multi-Platform SystemSciton, Inc · 2006 · 4 generations on221descendants
- K07306315W Ceralas D 1470NM Diode LaserBiolitec, Inc. · 2008 · 5 generations on202descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K990219 | Modification of Millennium | Biolase Technology, Inc. | 1999 | — |
| +1 | K012511 | Waterlase Millennium | Biolase Technology, Inc. | 2002 | — |
| +2 | K021508 | Opusduo EC Dental Laser System | Opusdent, Ltd. | 2002 | — |
| +3 | K040270 | Opusduo; Opusduo E; Opusduo EC; Opus 20; Opus Spectrum | Lumenis, Ltd. | 2004 | — |
| +4 | K060033 | Profile Multi-Platform System | Sciton, Inc | 2006 | — |
| +5 | K073063 | 15W Ceralas D 1470NM Diode Laser | Biolitec, Inc. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 0 |
| 2004 | 2 | 0 |
| 2006 | 3 | 0 |
| 2007 | 4 | 0 |
| 2008 | 11 | 0 |
| 2009 | 5 | 0 |
| 2010 | 9 | 0 |
| 2011 | 7 | 0 |
| 2012 | 4 | 0 |
| 2013 | 10 | 0 |
| 2014 | 11 | 0 |
| 2015 | 12 | 0 |
| 2016 | 10 | 0 |
| 2017 | 7 | 0 |
| 2018 | 13 | 0 |
| 2019 | 7 | 0 |
| 2020 | 14 | 0 |
| 2021 | 10 | 0 |
| 2022 | 24 | 0 |
| 2023 | 14 | 0 |
| 2024 | 24 | 0 |
| 2025 | 29 | 0 |
| 2026 | 15 | 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 MXF? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (5)
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 |
|---|---|---|---|
| * | — | Dental handpiece (Dentsply) Named without a submission number | |
| * | — | Dental handpiece (Star Dental) Named without a submission number | |
| * | — | Dental handpiece (Siemens) Named without a submission number | |
| * | — | Microetcher Ab Named without a submission number | |
| * | — | KV-1 Named without a submission number |
What descends from it? (247)
See all 2471 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K012511 | Waterlase Millennium | 2002 | 246 |
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?
- Of its descendants, K012511 (Biolase Technology, Inc., 2002) has gone furthest, with 246 descendants of its own.
How does its category compare?
All MXF devicesMXF System, Dental, Hydrokinetic, Caries Removal & Cavity Preparation: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MXF
FDA has decided no MXF device since 2007.
Median 510(k) review, days · MXF
Too few MXF 510(k)s in any year since 2007 to give a median.
Recalls per year · MXF
No recall names MXF since 2007.
Adverse event reports per year · MXF
No MAUDE report names MXF since 2007.
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 | — | 0 | 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 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Class I, II, III, IV and V cavity preparation
Caries removal
Hard tissue surface roughening or etching
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/K990219 · printed Nov 6, 2026
Cite this page
510(k) Report. “K990219: Modification of Millennium.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K990219
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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