# K051502: Spi Dental Implant

- Pathway: 510(k) (Special)
- Applicant: Thommen Medical AG
- Decided: Jun 21, 2005 after 14 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: 4 generations back to K894595 (1990). 19 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003034: Coltene Aura Compomer Restorative System, Coltene/Whaledent, Inc. (2000) Summary page 1.
- K022038: Spi Onetime Dental Implant, Paxmed International (2002) Summary page 1.
- K030689: Spi Element Dental Implant O 3.5 MM, Thommen Medical AG (2003) Summary page 1.
- K034014: Spi Contact Dental Implant, Thommen Medical AG (2004) Summary page 1.

## Most influential descendants
- 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® Dental Implant System, TST Surface, is intended to be surgically placed, either immediately or delayed, in the bone of the maxillary and/or mandibular arch to provide support for crowns, bridges or overdentures. SPI® Dental 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. Contraindications for the use of SPI® CONTACT implant 0 3.5 mm and SPI® ELEMENT implant o 3.5 mm: These implants are not suitable for applications in areas where pronounced rotation and translation movements occur, causing the implant to be subjected to large bending movements. - Restoration of posterior teeth in the upper or lower jaw - Single-tooth restoration of canines and central incisors in the upper jaw - Any application involving retentive anchors

Source page: https://510kreport.com/device/K051502
Methodology: https://510kreport.com/methodology