# K013798: Prosthetic Accessories to the Iti Dental Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Institut Straumann AG
- Decided: Dec 19, 2001 after 34 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: 2 generations back to K894844 (1990). 4 ancestors in all.
575 later devices descend from it; 4 cite it directly.
0 of 580 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.
- K003271: Modification to Iti Dental Implant System, Institut Straumann AG (2001) Summary page 1.
- K894844: Bonefit Implant System Accessories & Instruments, Straumann Institute, Ltd. (1990) Summary page 1.

## Most influential descendants
- K020096: Esthetic Ease Abutments for the Iti Dental Implant System (2002), 516 descendants of its own
- 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

## Indications for use
The abutment is placed into the dental implant to provide support for a prosthetic restoration such as a crown or bridge. The titanium temporary posts are screwed into the dental implants and serve as a base for a temporary prosthetic restoration. The plastic burn-out copings provide a cast inner surface for mating with the abutment and implant and are for use in casting restorations directly from porcelain-fused-to-metal alloy without the use of machined metal components. The healing cap and closure screw are titanium devices which are mounted onto the dental implant before the soft tissue is sutured in place around the implant and which are intended to protect the inner configuration of the implant. The healing cap also protects the outer 45° shoulder of the implant during the healing phase and helps stabilize and maintain the soft tissue.

Source page: https://510kreport.com/device/K013798
Methodology: https://510kreport.com/methodology