# K013891: Synocta Angled Abutments for the Iti Wide Neck Implant

- Pathway: 510(k) (Special)
- Applicant: Institut Straumann AG
- Decided: Feb 5, 2002 after 74 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: 3 generations back to K905434 (1992). 7 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K994119: Synocta Angled Abutments, Straumann USA (2000) Summary page 1.

## Most influential descendants
- K061500: Sicace Dental Implant System and Sic Angled Abutments (2006), 1 descendant of its own
- K073622: Easy Grip Dental Implant System (2008), 0 descendants of its own

## Indications for use
The ITI synOcta angled abutments for Wide Neck Implants are indicated for use in cases where the placement of an implant requires an angled reconstruction for an optimal result. The abutment can be used to restore crowns for single tooth replacements and bridges for multiple tooth restorations.

Source page: https://510kreport.com/device/K013891
Methodology: https://510kreport.com/methodology