# K991822: Allfit Implant System, Short Neck, Model Sti RT Length, Allfit Implant System, Long Neck, Model Sti RT LN Length

- Pathway: 510(k) (Traditional)
- Applicant: Dr. Ihde Dental AG Switzerland
- Decided: Aug 15, 2001 after 811 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 K894595 (1990). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983742: Iti Dental Implant System, Institut Straumann AG (1999) Summary page 1.
- K955281: Endosseous Dental Implant & Accessories, The Straumann Co. (1996) Summary page 1.

## Indications for use
The Allfit® STI implants are screw type endosseous dental implants made of commercially pure CP Titanium Grade 4. Provided the existence of adequate bone supply in terms of bone quality, bone width and height, Allfit® STI implants can be used for all indications requiring oral endosseous implants for functional, aesthetic rehabilitation of edentulous and partially dentate upper or lower jaws. The restoration may comprise: Single teeth replacement for gaps up to the width of Incisive and Premolars Bridge substitution in edentulous, partially or fully dentate jaws Bracing for orthodontist regulation systems Providing retention and support for dentures through bars and/or ball attachment The implants must be used only in conjunction with the associated original components and instruments of the system according to the indications and recommendations of Dr. Thde Dental AG. The surgical procedures must be preceded by a comprehensive and thorough patient evaluation, preoperative diagnostics, and treatment planning. Indications for 3.3 mm & STI implants: STI screw implants with an external diameter of 3.3 mm are considered options for placement in alveolar ridges of limited width (5-6 mm). Since the 3.3 mm diameter STI implants exhibit lower mechanical strength values compared to the 4.1 mm and 4.8 & STI implants, the 3.3 mm diameter screw implants should only be used for indications involving minimal loading. Indications for 4.8 mm I STI implants: 4.8 mm & STI screw implants can be used for all indications requiring oral, endosseous implants for functional, aesthetic rehabilitation of edentulous and partially dentate upper or lower jaws with a width of 7 mm or more. It is recommended to always use the longest and widest (diameter) implant. Hereby the possibly influencing forces must be taken into account. It is therefore recommended, not to use implants with small diameters in the posterior side for single teeth implantation. The anatomical and prosthetic conditions have to be taken into consideration. For a proper use of the STI implants, the consultation of The Allfit® STI instructions for use, provided by Dr. Ihde Dental AG, including the list of absolute, relative and local contraindications, is absolutely indispensable.

Source page: https://510kreport.com/device/K991822
Methodology: https://510kreport.com/methodology