# K010127: W & H Assistina

- Pathway: 510(k) (Traditional)
- Applicant: A-Dec, Inc.
- Decided: Oct 5, 2001 after 275 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.
6 later devices descend from it; 3 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K070074: Lubrina, Model Him-1 (2007), 3 descendants of its own
- K070297: Clearview Dental Handpiece Lubricator and Lubricant (2007), 1 descendant of its own
- 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

Source page: https://510kreport.com/device/K010127
Methodology: https://510kreport.com/methodology