# K022038: Spi Onetime Dental Implant

- Pathway: 510(k) (Special)
- Applicant: Paxmed International
- Decided: Jul 15, 2002 after 21 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
Longest line of descent: 1 generation back to K003045 (2001). 1 ancestor in all.
4 later devices descend from it; 2 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)
- K003045: HA-TI (Hand Titanium Screw) Implant, Hati Dental Ag. (2001)

## Most influential descendants
- K034014: Spi Contact Dental Implant (2004), 3 descendants of its own
- K051502: Spi Dental Implant (2005), 2 descendants of its own
- K093615: Spi Dental Implant, Element (2010), 1 descendant of its own
- K171795: Thommen Implant System (2017), 0 descendants of its own

## Indications for use
The Thommen SPI@ONETIME Dental Implant is intended to be surgically placed in the bone of the maxillary and/or mandibular arch to provide support for crowns, bridges or overdentures. SPI@ONETIME implants can be loaded immediately if they are splinted with a bar on four implants in the mandibular arch or six implants in the maxillary arch.

Source page: https://510kreport.com/device/K022038
Methodology: https://510kreport.com/methodology