# K093072: Starcare Handpiece Maintenance Unit

- Pathway: 510(k) (Traditional)
- Applicant: Dentalez, Inc.
- Decided: Dec 28, 2009 after 89 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
Longest line of descent: 2 generations back to K010127 (2001). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073319: Statmatic 31 Handpiece Maintenance Unit, Scican, Ltd. (2008) Summary page 1.
- K070074: Lubrina, Model Him-1, J. Morita USA, Inc. (2007) Summary page 1.
- K010127: W & H Assistina, A-Dec, Inc. (2001) Summary page 1.

## Indications for use
The StarCare Handpiece Maintenance Unit is intended for the internal cleaning, i.e purging of old lubricant, and the lubrication of air-driven high speed handpieces, electric micromotor attachments and turbines used in dentistry. StarCare Handpiece Maintenance Unit should be used only after the handpieces have been externally cleaned and prior to sterilization.

Source page: https://510kreport.com/device/K093072
Methodology: https://510kreport.com/methodology