# K070007: Spi Element Platform O 4.0 MM

- Pathway: 510(k) (Special)
- Applicant: Thommen Medical AG
- Decided: Jan 10, 2007 after 7 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 its predicate without a number.
- (no number) SPI® ELEMENT Dental Implant: named in the summary without a submission number

## Indications for use
The Thommen SPI® ELEMENT Dental Implant is intended to be surgically placed, either immediately after extraction or following healing, 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.

Source page: https://510kreport.com/device/K070007
Methodology: https://510kreport.com/methodology