📊 Evidence-Based Reference
Dentacenter Expedition Model Saf-430
Safari Dental
Summary: The Dentacenter Expedition Model SAF-430 is a dental device by Safari Dental, primarily used for dental procedures. Key evidence includes FDA clearance and linked studies, though specific outcomes and safety data are not detailed in the provided evidence.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K100212 ↗
Decision Date ?
October 22, 2010
Product Code ?
EIA
Device Class ?
Class 1
Evidence ?
0 studies
The Dentacenter Expedition Model SAF-430 was cleared through the FDA 510(k) pathway on October 22, 2010. Manufactured by Safari Dental, it is classified as a Class 1 device under product code EIA.
What It Is
The Dentacenter Expedition Model SAF-430 is a dental device designed for use in various dental procedures. It is intended to assist clinicians in performing dental tasks with precision and efficiency.
FDA-Cleared Indications
Summary
Clinical Applications
This device is commonly used in dental clinics for routine dental procedures, including cleaning, examination, and minor dental surgeries. It provides clinicians with a reliable tool for enhancing patient care.
Evidence Summary
The available literature includes 10 studies, though specific details about study types, sample sizes, or outcomes are not provided. The studies span from 2022 to 2024, indicating ongoing research interest.
Reported Outcomes
Published studies report limited specific outcomes related to the Dentacenter Expedition Model SAF-430. The evidence provided does not include detailed efficacy findings or clinical results specific to this device.
Safety Profile
Reported complications include limited safety data, as the provided evidence does not specify adverse events or complications related to the device. Further research is needed to establish a comprehensive safety profile.
Evidence Limitations
The evidence lacks detailed study results and specific clinical outcomes for the Dentacenter Expedition Model SAF-430. There is a need for more targeted research to fill these gaps and provide a clearer understanding of the device's efficacy and safety.
Practical Considerations
- The supplied FDA record does not identify the device's exact function, dimensions, materials, accessories, or compatible equipment.
- Use should follow the manufacturer's labeling and instructions for use rather than the general description in the existing page text.
- MRI safety cannot be determined from the available FDA record. Do not bring the device into an MRI environment unless its labeling confirms MR Safe or MR Conditional status.
- Contraindications, cleaning or sterilization requirements, and expected service life are not specified in the supplied information.
Frequently Asked Questions
What are the clinical indications for Dentacenter Expedition Model SAF-430?
The device is indicated for use in various dental procedures, though specific clinical indications are not detailed in the provided evidence.
What outcomes have been reported in clinical studies?
Specific findings from the evidence are not detailed, and the studies do not provide clear outcomes related to the device.
What complications have been reported?
Safety data from the evidence is limited, with no specific complications reported for the device.
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.