510(k) · Cleared
ClearedMillennium
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biolase Technology, Inc. · EFB Handpiece, Air-Powered, Dental
Cleared on Oct 8, 1998 after a 233-day review. The FDA summary names its predicate without a number. 247 later devices descend from it.
- Decided
- Oct 8, 1998
- Review
- 233 days
- Class
- Class I
- Product code
- EFB
- Recalls
- None
- Predicates
- 0
247 later devices descend from it, 1 citing it directly.
- This deviceK980585 MillenniumBiolase Technology, Inc. · 1998
- 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) | K980585 | Millennium | Biolase Technology, Inc. | 1998 | — |
| +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 EFB? 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 EFB device
- #1 K262144 DIAMED Handpiece;DIAMED Airmotor;DIAMED…score 13.3 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 Named without a submission number | |
| * | — | Dental handpiece Named without a submission number | |
| * | — | Dental handpiece 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 EFB devicesEFB Handpiece, Air-Powered, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EFB
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EFB
209in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EFB
No recall names EFB since 2007.
Adverse event reports per year · EFB
83in 2025
MAUDE reports naming product code EFB, 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 | 12 | 61 | 0 | 13 |
| 2008 | 7 | 97 | 0 | 19 |
| 2009 | 11 | 120 | 0 | 40 |
| 2010 | 8 | 116 | 0 | 78 |
| 2011 | 4 | 168 | 0 | 96 |
| 2012 | 8 | 130 | 0 | 97 |
| 2013 | 3 | 207 | 0 | 61 |
| 2014 | 7 | 200 | 0 | 73 |
| 2015 | 7 | 296 | 0 | 87 |
| 2016 | 3 | 205 | 0 | 122 |
| 2017 | 7 | 246 | 0 | 153 |
| 2018 | 3 | 210 | 0 | 81 |
| 2019 | 3 | 348 | 0 | 117 |
| 2020 | 5 | 259 | 0 | 94 |
| 2021 | 2 | — | 0 | 123 |
| 2022 | 5 | 430 | 0 | 157 |
| 2023 | 4 | 158 | 0 | 116 |
| 2024 | 5 | 209 | 0 | 104 |
| 2025 | 1 | — | 0 | 83 |
| 2026 | 4 | 252 | 0 | — |
What is it indicated for?
Class I, III and V cavity preparation for caries removal
Caries removal
Hard tissue surface roughening or etching
This device is to be used on adults 18 years of age or older.
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/K980585 · printed Nov 6, 2026
Cite this page
510(k) Report. “K980585: Millennium.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K980585
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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