# K061807: Spi Art Abutments

- Pathway: 510(k) (Traditional)
- Applicant: Thommen Medical AG
- Decided: Jul 31, 2006 after 34 days
- Product code: NHA (Abutment, Implant, Dental, Endosseous)
- Device class: 2
- Regulation: 21 CFR 872.3630
- 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® ART Abutments are intended to be used in conjunction with SPI® System dental implants in the maxillary and/or mandibular arch to provide support for crowns, bridges or overdentures. SPI ART Abutments are contraindicated for free-end bridges or bridges with more than one intermediate pontic element.

Source page: https://510kreport.com/device/K061807
Methodology: https://510kreport.com/methodology