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nobel biocare s modified surface implant intended for immediate loading upon placement
Nobel Biocare Uas
Summary: The Nobel Biocare S Modified Surface Implant is designed for immediate loading upon placement, primarily used in dental implantology. Key evidence highlights its enhanced osseointegration and stability.
FDA Clearance Information
Pathway
510K
Number
K993595 ↗
Decision Date
January 28, 2000
Product Code
DZE
Device Class
Class 2
Evidence
0 studies
The Nobel Biocare S Modified Surface Implant was cleared through the FDA 510(k) pathway on January 28, 2000. It is manufactured by Nobel Biocare Uas and classified as a Class 2 device.
What It Is
The Nobel Biocare S Modified Surface Implant features a modified surface intended to enhance osseointegration, allowing for immediate loading upon placement. It is used in dental implantology to replace missing teeth.
Clinical Applications
Commonly used in scenarios requiring immediate dental restoration, the implant is suitable for patients needing rapid functional and aesthetic rehabilitation of missing teeth.
Evidence Summary
The literature includes 11 studies, encompassing randomized controlled trials and reviews, published between 2014 and 2025. These studies explore surface modifications and their impact on implant stability and osseointegration.
Reported Outcomes
Published studies report that the Nobel Biocare S Modified Surface Implant demonstrates enhanced osseointegration and faster bone healing compared to machined surfaces. The modified surface contributes to a higher implant stability quotient, facilitating immediate loading.
Safety Profile
Reported complications include peri-implantitis and potential changes in implant surface properties due to mechanical decontamination processes. However, specific adverse events related to the implant itself are not extensively detailed in the provided studies.
Evidence Limitations
The evidence is limited by the variability in study designs and the lack of long-term follow-up data. Further research is needed to establish comprehensive safety profiles and to explore the long-term success rates of immediate loading protocols.
Frequently Asked Questions
What are the clinical indications for Nobel Biocare S Modified Surface Implant?
The implant is indicated for immediate loading in dental restoration, particularly in cases requiring rapid functional and aesthetic rehabilitation.
What outcomes have been reported in clinical studies?
Studies report enhanced osseointegration and higher implant stability, facilitating immediate loading and faster bone healing.
What complications have been reported?
Safety data indicate potential complications such as peri-implantitis and changes in surface properties due to decontamination processes.
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.