# K190509: Lubrina 2

- Pathway: 510(k) (Traditional)
- Applicant: J. Morita USA, Inc.
- Decided: Mar 4, 2020 after 369 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). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070074: Lubrina, Model Him-1, J. Morita USA, Inc. (2007) Summary page 9.

## Indications for use
The Lubrina 2 is for lubricating and cleaning the inside of dental instruments.

Source page: https://510kreport.com/device/K190509
Methodology: https://510kreport.com/methodology