# K090154: Spi Dental Implant Inicell

- Pathway: 510(k) (Traditional)
- Applicant: Thommen Medical AG
- Decided: Jul 27, 2009 after 186 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.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## 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
SPI® Dental Implant, INICELL® is for one-stage or two-stage surgical procedures. SPI Dental Implant, INICELL 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 INICELL implant 0 3.5 mm and SPI CONTACT INICELL 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/K090154
Methodology: https://510kreport.com/methodology