# K030689: Spi Element Dental Implant O 3.5 MM

- Pathway: 510(k) (Special)
- Applicant: Thommen Medical AG
- Decided: Mar 26, 2003 after 21 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: 1 generation back to K901927 (1991). 2 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003045: HA-TI (Hand Titanium Screw) Implant, Hati Dental Ag. (2001)
- K901927: HA-TI (Hand-Titanium Screw) Implant, Mathys Corp. of North America (1991) Summary page 1.

## Most influential descendants
- K034014: Spi Contact Dental Implant (2004), 3 descendants of its own
- 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 ELEMENT Dental Implant is intended to be surgically placed in the bone of the maxillary and/or mandibular arch to provide support for crowns, bridges or overdentures. SPl@ELEMENT implant 0 3.5 mm should be employed only at locations where the available bone structure (minimum width of alveolar ridge: 5-6 mm) precludes the use of a larger diameter. Blocking of multiple SPJ? ELEMENT implants 0 3.5 mm is recommended whenever possible. 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 (e.g. use of single implants for the restoration of canines). Partially edentulous lower and upper jaw: $PI@ELEMENT implants 0 3.5 mm are suitable for alloplastic replacement of the lateral incisors (12,22 = FDI System) in the upper jaw and the central and lateral incisors (41,31,42 and 32 = FDI System) in the lower jaw. Edentulous lower jaw: 4 SPP ELEMENT implant 0 3.5 mm connected with a bar Edentulous lower and upper jaw: Complete bridges in combination with 0 4.2 mm, 5.0 mm or 6.0 mm SPI@implants Contraindications for the use of SPI$ ELEMEm implant 0 3.5 mm: - 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/K030689
Methodology: https://510kreport.com/methodology