# K012511: Waterlase Millennium

- Pathway: 510(k) (Traditional)
- Applicant: Biolase Technology, Inc.
- Decided: Jan 18, 2002 after 165 days
- Product code: MXF (System, Dental, Hydrokinetic, Caries Removal & Cavity Preparation)
- Device class: 2
- Regulation: 21 CFR 872.4120
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K922901 (1992). 14 ancestors in all.
246 later devices descend from it; 3 cite it directly.
0 of 261 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991994: Twilight, Biolase Technology, Inc. (1999) Summary page 2.
- K981379: Aurora, Premier Laser Systems, Inc. (1998) Summary page 2.
- K980585: Millennium, Biolase Technology, Inc. (1998) Summary page 2.
- K990219: Modification of Millennium, Biolase Technology, Inc. (1999) Summary page 2.
- K962031: Quantec Series 2000 Endodontic Files, Tycom Dental (1996) Summary page 2.
- K970339: Tri Auto ZX, J. Morita USA, Inc. (1997) Summary page 3.

## Most influential descendants
- K021508: Opusduo EC Dental Laser System (2002), 240 descendants of its own
- K040270: Opusduo; Opusduo E; Opusduo EC; Opus 20; Opus Spectrum (2004), 226 descendants of its own
- K060033: Profile Multi-Platform System (2006), 221 descendants of its own
- K073063: 15W Ceralas D 1470NM Diode Laser (2008), 202 descendants of its own
- K083613: Quanta System Polysurge Diode Laser Family (2008), 192 descendants of its own

## Indications for use
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

Source page: https://510kreport.com/device/K012511
Methodology: https://510kreport.com/methodology