# K023645: Spi Easy Dental Implant Abutment

- Pathway: 510(k) (Special)
- Applicant: Thommen Medical AG
- Decided: Nov 13, 2002 after 14 days
- Product code: NHA (Abutment, Implant, Dental, Endosseous)
- Device class: 2
- Regulation: 21 CFR 872.3630
- Recalls of this device: 1 (0 Class I)
- 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.
34 later devices descend from it; 4 cite it directly.
0 of 37 devices in its family (counting itself) have a Class I recall.

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

## Most influential descendants
- K031747: Spi Dental Implant Abutments (2003), 33 descendants of its own
- K121334: Varioeco (2012), 16 descendants of its own
- K160244: VARIOunite (2016), 15 descendants of its own
- K163634: External Hex Implants (2017), 13 descendants of its own
- K033346: Spi Easy Dental Implant Protective Cap (2003), 12 descendants of its own

## Recalls of this device
- Apr 19, 2007 · Not classified · Z-1086-2007: The undercut on the SPI EASY abutments which engages the stabilization ring of the implant is missing. Although the abutments can still be placed on the implant by the user the parts do not fulfill th

## Indications for use
Thommen SPI@EASY Dental Implant Abutments are intended to be used in conjunction with SPI@System dental implants in the maxillary andor mandibular arch to provide support for crowns, bridges or overdentures.

Source page: https://510kreport.com/device/K023645
Methodology: https://510kreport.com/methodology