# K990908: Millennium

- Pathway: 510(k) (Traditional)
- Applicant: Endo Technic Corp.
- Decided: May 27, 1999 after 70 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.
No later device cites it as a predicate yet.
0 of 1 device 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) Microetcher Ab: named in the summary without a submission number
- (no number) KV-1: named in the summary without a submission number

## Indications for use
For use on adult and pediatric patients for the following: 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

Source page: https://510kreport.com/device/K990908
Methodology: https://510kreport.com/methodology