# K980585: Millennium

- Pathway: 510(k) (Traditional)
- Applicant: Biolase Technology, Inc.
- Decided: Oct 8, 1998 after 233 days
- Product code: EFB (Handpiece, Air-Powered, Dental)
- Device class: 1
- Regulation: 21 CFR 872.4200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
247 later devices descend from it; 1 cites it directly.
0 of 248 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: named in the summary without a submission number
- (no number) Dental handpiece: named in the summary without a submission number
- (no number) Dental handpiece: named in the summary without a submission number
- (no number) Microetcher Ab: named in the summary without a submission number
- (no number) KV-1: named in the summary without a submission number

## Most influential descendants
- K012511: Waterlase Millennium (2002), 246 descendants of its own
- 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

## Indications for use
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.

Source page: https://510kreport.com/device/K980585
Methodology: https://510kreport.com/methodology