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510(k) Data Aggregation
K Number
K033689Device Name
OSSTELL MENTOR RFA
Manufacturer
INTEGRATION DIAGNOSTICS LTD
Date Cleared
2004-02-26
(94 days)
Product Code
EKX
Regulation Number
872.4200Why did this record match?
Applicant Name (Manufacturer) :
INTEGRATION DIAGNOSTICS LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Osstell Mentor is indicated for use in measuring the stability of implants in the oral cavity and craniofacial region. The Osstell Mentor can add important information to the evaluation of implant stability and can be used as part of an overall treatment evaluation program. The final implant treatment decisions are the responsibility of the surgeon.
Device Description
The Osstell Mentor Resonance Frequency Analyzer (RFA) is an updated version of the Osstell™ (K003714), the system designed to measure dental implant stability in the oral cavity and craniofacial region. Similar to K003714, the Osstell Mentor is a portable, handheld instrument that involves the use of the noninvasive technique, Resonance Frequency Analysis. The updated system involves the use of a Smartpeg (aluminum rod) attached to the dental implant by means of a screw. The Smartpeg is excited by a magnetic pulse from the measurement probe on the handheld instrument. The resonance frequency, which is the measure of implant stability, is calculated from the response signal. Results are displayed as the Implant Stability Quotient (ISQ). The ISQ is a measurement of the stability of the implant and is derived from the resonance frequency value obtained from the Smartpeg.
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K Number
K003714Device Name
OSSTELL RESONANCE FREQUENCY ANALYZER
Manufacturer
INTEGRATION DIAGNOSTICS LTD
Date Cleared
2001-08-09
(251 days)
Product Code
EKX
Regulation Number
872.4200Why did this record match?
Applicant Name (Manufacturer) :
INTEGRATION DIAGNOSTICS LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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