# K020096: Esthetic Ease Abutments for the Iti Dental Implant System

- Pathway: 510(k) (Special)
- Applicant: Institut Straumann AG
- Decided: Feb 8, 2002 after 28 days
- Product code: DZE (Implant, Endosseous, Root-Form)
- Device class: 2
- Regulation: 21 CFR 872.3640
- 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: 3 generations back to K894844 (1990). 5 ancestors in all.
516 later devices descend from it; 2 cite it directly.
0 of 522 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990342: Synocta Prosthetics, Straumann USA (1999) Summary page 1.
- K013798: Prosthetic Accessories to the Iti Dental Implant System, Institut Straumann AG (2001) Summary page 1.

## Most influential descendants
- K033243: Iti Synocta Meso Abutments (2003), 514 descendants of its own
- K062129: P.0004 Implants (2006), 434 descendants of its own
- K041236: Procera Implant Bridge, Models 15-1001, 15-1002, 15-1051, 15-1052 (2004), 328 descendants of its own
- K043042: Procera Implant Bridge, Models 15-1001, 15-1002, 15-1051, 15-1052 (2004), 327 descendants of its own
- K090069: Procera Implant Bridge Overdenture (2009), 313 descendants of its own

## Recalls of this device
- Jun 6, 2005 · Not classified · Z-0975-05: Basal screw is too short to adequately hold the dental abutment in the implant

## Indications for use
Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns or bridges. The ITI Esthetic abutments are indicated for cemented restorations in esthetic areas of the mouth. The abutment can be used to restore crowns for single tooth replacements and bridges for multiple tooth restorations.

Source page: https://510kreport.com/device/K020096
Methodology: https://510kreport.com/methodology