510(k) · Cleared
ClearedWaterlase 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 Jan 18, 2002 as substantially equivalent to K991994 (Biolase Technology, Inc., 1999) and 5 other predicates after a 165-day review. Its family tree reaches back 3 generations to 1992. 246 later devices descend from it.
- Decided
- Jan 18, 2002
- Review
- 165 days
- Class
- Class II
- Product code
- MXF
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 3 generations to K922901 (1992). 14 ancestors in all. 246 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK922901 Incisor I Pulsed ND:Yag Laser SystemBuckman Co., Inc. · 1992
- 2 generations backK972325 Pulsemaster 1000 ST Dental Laser SystemAmerican Dental Technologies, Inc. · 1997
- 1 generation backK991994 TwilightBiolase Technology, Inc. · 1999
- This deviceK012511 Waterlase MillenniumBiolase Technology, Inc. · 2002
- Descendant · cites it directly · 240 of its ownK021508 Opusduo EC Dental Laser SystemOpusdent, Ltd. · 2002
- Descendant · 2 generations on · 226 of its ownK040270 Opusduo; Opusduo E; Opusduo EC; Opus 20; Opus SpectrumLumenis, Ltd. · 2004
- Descendant · 3 generations on · 221 of its ownK060033 Profile Multi-Platform SystemSciton, Inc · 2006
- Descendant · 4 generations on · 202 of its ownK073063 15W Ceralas D 1470NM Diode LaserBiolitec, Inc. · 2008
- Descendant · 5 generations on · 192 of its ownK083613 Quanta System Polysurge Diode Laser FamilyQuanta System Spa · 2008
Showing 5 of 246 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 246 · See all- K021508Opusduo EC Dental Laser SystemOpusdent, Ltd. · 2002 · cites it directly240descendants
- K040270Opusduo; Opusduo E; Opusduo EC; Opus 20; Opus SpectrumLumenis, Ltd. · 2004 · 2 generations on226descendants
- K060033Profile Multi-Platform SystemSciton, Inc · 2006 · 3 generations on221descendants
- K07306315W Ceralas D 1470NM Diode LaserBiolitec, Inc. · 2008 · 4 generations on202descendants
- K083613Quanta System Polysurge Diode Laser FamilyQuanta System Spa · 2008 · 5 generations on192descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K922901 | Incisor I Pulsed ND:Yag Laser System | Buckman Co., Inc. | 1992 | — |
| −2 | K972325 | Pulsemaster 1000 ST Dental Laser System | American Dental Technologies, Inc. | 1997 | — |
| −1 | K991994 | Twilight | Biolase Technology, Inc. | 1999 | — |
| 0 (this device) | K012511 | Waterlase Millennium | Biolase Technology, Inc. | 2002 | — |
| +1 | K021508 | Opusduo EC Dental Laser System | Opusdent, Ltd. | 2002 | — |
| +2 | K040270 | Opusduo; Opusduo E; Opusduo EC; Opus 20; Opus Spectrum | Lumenis, Ltd. | 2004 | — |
| +3 | K060033 | Profile Multi-Platform System | Sciton, Inc | 2006 | — |
| +4 | K073063 | 15W Ceralas D 1470NM Diode Laser | Biolitec, Inc. | 2008 | — |
| +5 | K083613 | Quanta System Polysurge Diode Laser Family | Quanta System Spa | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 4 | 0 |
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 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? (6)
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 |
|---|---|---|---|
| * | K991994 | TwilightSummary page 2…aterlase Millennium is substantially equivalent to several erbium laser systems and diode laser systems cleared by the FDA. Equivalent devices include: BioLase, Twilite (K991994, for oral soft tissues including pulpotomy and pulpotomy as an adjunct to root canal therapy); Premier, Aurora (K981379, for pulp… | 1999 |
| * | K981379 | AuroraSummary page 2…DA. Equivalent devices include: BioLase, Twilite (K991994, for oral soft tissues including pulpotomy and pulpotomy as an adjunct to root canal therapy); Premier, Aurora (K981379, for pulpotomy and pulpotomy as an adjunct to root canal therapy); BioLase, Millennium (K980585 and K990219 for hard tissue appli… | 1998 |
| * | K980585 | MillenniumSummary page 2…tomy and pulpotomy as an adjunct to root canal therapy); Premier, Aurora (K981379, for pulpotomy and pulpotomy as an adjunct to root canal therapy); BioLase, Millennium (K980585 and K990219 for hard tissue applications); Tycom Dental, Quantec Series 2000 Endodontic Files (K962031 for root canal === Page 3… | 1998 |
| * | K990219 | Modification of MillenniumSummary page 2…potomy as an adjunct to root canal therapy); Premier, Aurora (K981379, for pulpotomy and pulpotomy as an adjunct to root canal therapy); BioLase, Millennium (K980585 and K990219 for hard tissue applications); Tycom Dental, Quantec Series 2000 Endodontic Files (K962031 for root canal prepara… | 1999 |
| * | K962031 | Quantec Series 2000 Endodontic FilesSummary page 2…lpotomy as an adjunct to root canal therapy); BioLase, Millennium (K980585 and K990219 for hard tissue applications); Tycom Dental, Quantec Series 2000 Endodontic Files (K962031 for root canal preparation) and Tulsa Dental Products, Tri Auto ZX (K970339 for endodontic treatment to enlarge r… | 1996 |
| * | K970339 | Tri Auto ZXSummary page 3…ard tissue applications); Tycom Dental, Quantec Series 2000 Endodontic Files (K962031 for root canal preparation) and Tulsa Dental Products, Tri Auto ZX (K970339 for endodontic treatment to enlarge root canals). Conclusion: Waterlase Millennium is substantially equivalent to several avail… | 1997 |
What descends from it? (246)
See all 2463 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 10 years and passes through 3 companies; a new generation was cleared every 2.4 years on median.
- None of the 14 ancestors has a recall.
- Of its descendants, K021508 (Opusdent, Ltd., 2002) has gone furthest, with 240 descendants of its own.
- 2 other devices also cite its predicate K991994.
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?
Tooth preparation to obtain access to root canal
Pulpotomy
Pulp extirpation
Pulpotomy as an adjunct to root canal therapy
Root canal debridement and cleaning
Root canal preparation including enlargement
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/K012511 · printed Nov 6, 2026
Cite this page
510(k) Report. “K012511: Waterlase Millennium.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012511
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026