# K003045: HA-TI (Hand Titanium Screw) Implant

- Pathway: 510(k) (Traditional)
- Applicant: Hati Dental Ag.
- Decided: Jul 12, 2001 after 286 days
- Product code: DZE (Implant, Endosseous, Root-Form)
- Device class: 2
- Regulation: 21 CFR 872.3640
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
41 later devices descend from it; 5 cite it directly.
0 of 42 devices in its family (counting itself) have a Class I recall.

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

## Most influential descendants
- K023645: Spi Easy Dental Implant Abutment (2002), 34 descendants of its own
- K031747: Spi Dental Implant Abutments (2003), 33 descendants of its own
- K121334: Varioeco (2012), 16 descendants of its own
- K160244: VARIOunite (2016), 15 descendants of its own
- K163634: External Hex Implants (2017), 13 descendants of its own

Source page: https://510kreport.com/device/K003045
Methodology: https://510kreport.com/methodology