đź“Š Evidence-Based Reference
integral omniloc dental implant with interface ring
Calcitek
Summary: The Integral Omniloc dental implant by Calcitek is a hydroxyapatite-coated endosseous implant primarily used for single-tooth replacement. Key evidence highlights its success and maintenance requirements over a 5-year period.
FDA Clearance Information
Pathway
510K
Number
K941608 ↗
Decision Date
May 5, 1995
Product Code
DZE
Device Class
Class 2
Evidence
0 studies
The Integral Omniloc dental implant was cleared by the FDA through the 510(k) pathway on May 5, 1995. It is manufactured by Calcitek and classified as a Class 2 device under product code DZE.
What It Is
The Integral Omniloc dental implant is a hydroxyapatite-coated endosseous implant designed for dental applications, specifically for single-tooth replacement. It integrates with the bone to provide a stable foundation for dental prosthetics.
Clinical Applications
This implant is commonly used in scenarios requiring single-tooth replacement, particularly in cases where a stable and durable solution is needed. It is suitable for patients requiring a reliable dental restoration option.
Evidence Summary
The available literature includes three studies, with a prospective study evaluating success over 5 years and others examining stress distribution and angled abutment use. The studies span from 1992 to 2004.
Reported Outcomes
Published studies report that the Integral Omniloc dental implant demonstrates success in single-tooth replacement, with a focus on maintenance requirements over a 5-year period. The influence of abutment angulation on stress distribution was also explored, indicating differences between preangled and straight abutments.
Safety Profile
Reported complications include variations in stress distribution along the implant/bone interface, particularly with different abutment angulations. No specific adverse events were detailed in the provided studies.
Evidence Limitations
The evidence is limited by the small number of studies and the lack of detailed safety data. Further research is needed to explore long-term outcomes and potential complications in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for Integral Omniloc dental implant?
The Integral Omniloc dental implant is indicated for single-tooth replacement, providing a stable and durable solution for dental restoration.
What outcomes have been reported in clinical studies?
Studies have reported success in single-tooth replacement and maintenance over a 5-year period, with considerations for abutment angulation affecting stress distribution.
What complications have been reported?
Reported complications include variations in stress distribution with different abutment angulations, though specific adverse events were not detailed.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.