# K013908: Waterlase Millennium

- Pathway: 510(k) (Traditional)
- Applicant: Biolase Technology, Inc.
- Decided: Feb 12, 2002 after 78 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
No predicates in its family tree.
9 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Dental handpiece - Dentsply: named in the summary without a submission number
- (no number) Dental handpiece Star Dental: named in the summary without a submission number
- (no number) Dental handpiece Siemens: named in the summary without a submission number

## Most influential descendants
- K030523: Waterlase (2004), 8 descendants of its own
- K052354: Oculase MD (2006), 5 descendants of its own
- K063867: Cutera ER:Ysgg Laser Handpiece (2007), 2 descendants of its own
- K080530: Modification to Cutera ER:Ysgg Laser Handpiece (2008), 1 descendant of its own
- K081589: Waterlase, Version 3.0 (2008), 1 descendant of its own

## Indications for use
Class I, II, III, IV and V cavity preparation. Caries removal, Hard tissue surface roughening or etching. Enameloplasty, excavation of pits and fissures for placement of sealants. Cutting, shaving, contouring and resection of oral osseous tissues (bone).

Source page: https://510kreport.com/device/K013908
Methodology: https://510kreport.com/methodology