# K060958: Straumann Narrow Neck Implants

- Pathway: 510(k) (Traditional)
- Applicant: Straumann USA
- Decided: Aug 24, 2006 after 139 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: 8 generations back to K894595 (1990). 45 ancestors in all.
228 later devices descend from it; 2 cite it directly.
0 of 274 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010291: Iti Dental Implant System, Straumann USA (2001) Summary page 1.
- K030007: Iti Dental Implant System, Straumann USA (2003) Summary page 1.
- K053088: Slactive Implants, Institut Straumann AG (2006) Summary page 1.
- K021318: Xive Dental Implant System, Friadent GmbH (2002) Summary page 1.
- K024111: Astra Tech Implants-Dental System Fixture Osseospeed, Astra Tech, Inc. (2003) Summary page 1.
- K022562: Various Branemark System Implants-Immediate Function Indication, Nobel Biocare AB (2002) Summary page 1.
- K023113: Replace Tiunite Endosseous Implant, Nobel Biocare Uas, Inc. (2002) Summary page 1.

## Most influential descendants
- K111357: Straumann Narrow Neck Crossfit (NNC) 03.3MM Dental Implant System (2011), 222 descendants of its own
- K113283: NNC Cementable Abutment Straight,15 Degree Angle, Type a ,15 Degree Angle, Type B,NNC Basal Screw  Cementable Abutments (2011), 166 descendants of its own
- K120822: Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN, Straumann Cares Variobase Abutment WN, ST (2012), 165 descendants of its own
- K150203: Medentika CAD/CAM Abutments (2015), 129 descendants of its own
- K123784: Straumann Dental Implant System (2013), 122 descendants of its own

## Indications for use
Straumann Narrow Neck implants are intended for single-stage or two-stage surgical placement in the maxillary and/or mandibular arches to provide support for prosthetic restorations in edentulous or partially edentulous patients. Straumann Narrow Neck implants are intended for immediate function on single tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function. Multiple tooth applications may be rigidly splinted. In the case of edentulous patients, four or more implants must be used in immediately loaded cases.

Source page: https://510kreport.com/device/K060958
Methodology: https://510kreport.com/methodology