# K062129: P.0004 Implants

- Pathway: 510(k) (Special)
- Applicant: Institut Straumann AG
- Decided: Oct 20, 2006 after 86 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: 5 generations back to K894844 (1990). 8 ancestors in all.
434 later devices descend from it; 31 cite it directly.
0 of 443 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012757: Iti Dental Implant System, Straumann USA (2001) Summary page 1.
- K033243: Iti Synocta Meso Abutments, Straumann USA (2003) Summary page 1.

## Most influential descendants
- K070478: P.004 RC Temporary Abutment, P.004 Temporary Healing Abutment (Cap) (2007), 283 descendants of its own
- K072679: P.004 Abutments (2007), 279 descendants of its own
- K072151: P.004 RC Cares Titanium and Ceramic Abutments (2007), 264 descendants of its own
- K081005: P.004 NC Cares Titanium and Ceramic Abutments (2008), 263 descendants of its own
- K100152: Sirona Cad/Cam System (2010), 240 descendants of its own

## Indications for use
The P.004 Implants are intended for immediate, delayed or conventional placement in the maxilla and/or mandibular arches to support crowns bridges or overdentures in edentulous or partially edentulous patients. They are intended for immediate function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. Multiple tooth applications may be rigidly splinted. In the case of edentulous patients, 4 or more implants must be used. Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns or bridges. Meso abutments are indicated for cemented restorations particularly in esthetic areas of the mouth. The abutment can be used in single tooth replacements and multiple tooth restorations.

Source page: https://510kreport.com/device/K062129
Methodology: https://510kreport.com/methodology