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510(k) Data Aggregation
K Number
K991822Device Name
ALLFIT IMPLANT SYSTEM, SHORT NECK, MODEL STI RT LENGTH, ALLFIT IMPLANT SYSTEM, LONG NECK, MODEL STI RT LN LENGTH
Manufacturer
Date Cleared
2001-08-15
(811 days)
Product Code
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
DR. IHDE DENTAL AG SWITZERLAND
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended 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. Ihde 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 ØSTI 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 Ø STI implants, the 3.3 mm diameter screw implants should only be used for indications involving minimal loading.
Indications for 4.8 mm ØSTI implants:
4.8 mm Ø 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.
Device Description
The implants, produced from CP titanium 4, are available is in three diameters (3.1; 4.1 and 4.8 mm) and 6 insertion lengths: (7, 9, 11, 13, 15 and 17) respectively (8, 10, 12, 14, 16 and 18 for the long neck STI implants). The neck of the implant, which remains above the bone crest after the implantation, is a smooth machined surface to permit the attachment of epithelial tissue.
The STI implants are characterized through a rotation symmetrical structure with a thread showing high thread intervals. The thread interval depends on the implant diameter: 1 mm for the implants of 3.3 mm diameter, and 1.25 mm for the implants of 4.1 and 4.8 mm diameter. The main feature of the thread form is the 75° orientation of the surface of the thread to the implant axis, rather than parallel to the implant axis, and so directing compressive forces into the bone.
The outside contact area between the implant and its abutment shows a slope of 45° to maximize prosthesis stability, otherwise this area is flat. The implant does not possess any inside or outside hex. The rotation secured screw (against the abutment) occurs over the friction of the inside cone, hereby the inside screw thread M2 pulls against the cone. The creation of high adhesion friction fit leads to a secure connection of implant and abutment. Single crowns can be screwed on the implant, if secured abutments (for example OSA STI) are used.
Allfit STI-implants are available in two neck heights: 1.8 mm and 2.8 mm, however the total length of the implant is always identical. Therefore the endosseous part is smaller in the case of 2.8mm neck height. The choice between the 2 alternatives depend on the clinical situation of the soft tissue: In the molar region, thick soft tissues are usually suitable for the long neck, while in the anterior region, esthetic aspects and thin soft tissue are suitable for smaller neck portions.
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