# K093615: Spi Dental Implant, Element

- Pathway: 510(k) (Traditional)
- Applicant: Thommen Medical AG
- Decided: Mar 4, 2010 after 101 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: 7 generations back to K894595 (1990). 56 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 58 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090154: Spi Dental Implant Inicell, Thommen Medical AG (2009)
- K051502: Spi Dental Implant, Thommen Medical AG (2005) Summary page 2.
- K050712: 4.5.* 6.0MM Dental Implant and 6.0*6.0 MM Dental Implant, Bicon, Inc. (2005) Summary page 2.
- K050258: Groovy Implants, Nobel Biocare AB (2005) Summary page 2.
- K033984: Straumann Dental Implant System, Institut Straumann AG (2004) Summary page 2.
- K010185: 6.0 X 5.7MM Dental Implant, Bicon, Inc. (2002) Summary page 2.
- K926501: Branemark System (R) - 5.5MM Fixture, Nobelpharma USA, Inc. (1993) Summary page 2.

## Most influential descendants
- K171795: Thommen Implant System (2017), 0 descendants of its own

## Indications for use
SPI® Dental Implant, ELEMENT is for one-stage or two-stage surgical procedures. SPI Dental Implant, ELEMENT is intended for immediate placement and function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. Multiple tooth applications may be rigidly splinted. In the case of edentulous patients, four or more implants must be used in immediately loaded cases. Contraindications for the use of SPI ELEMENT implant 0 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 and 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/K093615
Methodology: https://510kreport.com/methodology