# K072649: Spi System Dental Implants

- Pathway: 510(k) (Traditional)
- Applicant: Thommen Medical AG
- Decided: Dec 6, 2007 after 78 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.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
SPI® System Dental Implants are for one-stage or two-stage surgical procedures. SPI System Dental Implants are 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 and SPI® CONTACT 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 retentivefchors.

Source page: https://510kreport.com/device/K072649
Methodology: https://510kreport.com/methodology