# K070074: Lubrina, Model Him-1

- Pathway: 510(k) (Traditional)
- Applicant: J. Morita USA, Inc.
- Decided: May 31, 2007 after 143 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: 1 generation back to K010127 (2001). 2 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012308: Kavo Quattrocare, Kavo America (2002) Summary page 2.
- K010127: W & H Assistina, A-Dec, Inc. (2001) Summary page 2.

## Most influential descendants
- K190509: Lubrina 2 (2020), 0 descendants of its own
- K103697: Torqtech (2012), 0 descendants of its own
- K093072: Starcare Handpiece Maintenance Unit (2009), 0 descendants of its own

## Indications for use
LUBRINA HIM-I is intended for internal cleaning, i.e., purging of old lubricant, for the maintenance of rotating dental and surgical instruments. NOTE: LUBRiNA HIM-1 should be used only with pre-cleaned dental handpieces and before they are sterilized. CAUTION: FEDERAL (US) law restricts the use of this device to licensed professionals.

Source page: https://510kreport.com/device/K070074
Methodology: https://510kreport.com/methodology