# K034014: Spi Contact Dental Implant

- Pathway: 510(k) (Traditional)
- Applicant: Thommen Medical AG
- Decided: Mar 5, 2004 after 72 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: 3 generations back to K894595 (1990). 17 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K901927: HA-TI (Hand-Titanium Screw) Implant, Mathys Corp. of North America (1991) Summary page 3.
- K003045: HA-TI (Hand Titanium Screw) Implant, Hati Dental Ag. (2001) Summary page 3.
- K022038: Spi Onetime Dental Implant, Paxmed International (2002) Summary page 3.
- K030689: Spi Element Dental Implant O 3.5 MM, Thommen Medical AG (2003) Summary page 3.
- K030007: Iti Dental Implant System, Straumann USA (2003) Summary page 3.
- K964220: Replace Titanium Implant System, Steri-Oss, Inc. (1997) Summary page 3.
- K022562: Various Branemark System Implants-Immediate Function Indication, Nobel Biocare AB (2002) Summary page 3.

## Most influential descendants
- 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® CONTACT Dental Implant is intended to be surgically placed, either immediately or delayed, in the bone of the maxillary or mandibular arch to provide support for crowns, bridges or overdentures. SPI® CONTACT 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 implants 0 3.5 mm: These implants are not suitable for applications in areas where pronounced rotation moments. translation movements occur, causing the implant to be subjected to large bending moments. - 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/K034014
Methodology: https://510kreport.com/methodology