# K984104: Iti Dental Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Straumann USA
- Decided: May 13, 1999 after 177 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: 1 generation back to K894595 (1990). 8 ancestors in all.
1,043 later devices descend from it; 10 cite it directly.
0 of 1,052 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K894595: Bonefit R Screw Implants, Institut Straumann AG (1990) Summary page 1.
- K971578: Endosseous Dental Implant, Straumann USA (1997) Summary page 1.
- K925765: Branemark System Standard 3.75MM Fixture, Nobelpharma USA, Inc. (1993) Summary page 1.
- K934825: Branemark System, Nobelpharma USA, Inc. (1994) Summary page 1.
- K954347: 3I Standard Threaded Implant, Implant Innovations, Inc. (1996) Summary page 1.
- K960417: 3I STND Threaded/Self Tapping Threaded/3I Miniplant Implants/3 I Emergence Prof. Temp. Healing Abutments, Implant Innovations, Inc. (1996) Summary page 1.
- K981516: Sterngold Implamed Hex Screw Implant TPS Coated Sterngold Implamed Hex Screw Implant HA Coated , Refer to Table 1 in Sub, Sterngold/Implamed (1998) Summary page 1.
- K930071: Sargon Cylindro-Blade Implant, Sargon Ent., Inc. (1994) Summary page 1.

## Most influential descendants
- K993595: Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon Placement) (2000), 942 descendants of its own
- K992937: Dental Implant (2000), 735 descendants of its own
- K023113: Replace Tiunite Endosseous Implant (2002), 689 descendants of its own
- K041661: Nobel Biocare Endosseous Implants (2004), 622 descendants of its own
- K030007: Iti Dental Implant System (2003), 570 descendants of its own

## Recalls of this device
- Apr 25, 2003 · Not classified · Z-0871-03: Hemoglobin interference limitation revised downward; hemolyzed samples may result in false negative results.

## Indications for use
ITI One Part octa implants are intended for surgical placement in the maxillary; and/or mandibular arches to provide support for prosthetic restorations in edentulous or partially edentulous patients. ITI one-part octa implants are for use in edentulous jaws in conjunction with bar-borne superstructure on 4 implants. If ITI one-part implants are splinted with a bar, they can be loaded immediately. ITI one-part implants can also be used for indications requiring endosseous implants for functional rehabilitation in regions where an ITI two part implant and an Octa abutment would normally be used.

Source page: https://510kreport.com/device/K984104
Methodology: https://510kreport.com/methodology