# K071453: Spi Easy 4.0 Abutment

- Pathway: 510(k) (Special)
- Applicant: Thommen Medical AG
- Decided: Sep 19, 2007 after 117 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.
19 later devices descend from it; 3 cite it directly.
0 of 20 devices 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 EASY Dental Implant Abutment: named in the summary without a submission number

## Most influential descendants
- 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
- K193084: TIB Abutment System (2020), 3 descendants of its own
- K183024: Implacil Implant System (2020), 2 descendants of its own

## Indications for use
The Thommen SPI® EASY 0 4.0 Abutment is 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.

Source page: https://510kreport.com/device/K071453
Methodology: https://510kreport.com/methodology