Search Results
Found 4 results
510(k) Data Aggregation
K Number
K181888Device Name
Osstell Beacon
Manufacturer
Osstell AB
Date Cleared
2019-08-22
(405 days)
Product Code
EKX
Regulation Number
872.4200Why did this record match?
Applicant Name (Manufacturer) :
Osstell AB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Osstell Beacon is indicated for use in measuring the stability of implants in the oral cavity and maxillofacial region.
Device Description
The Osstell Beacon is a modification of the Osstell ISQ (K082523). The system is designed to measure implant stability in the oral cavity and maxillofacial region. Similar to K082523, the Osstell Beacon is a portable, handheld instrument that involves the use of the noninvasive technique, Resonance Frequency Analysis. The system involves the use of a Smartpeg (aluminum rod) attached to the implant by means of a screw. The Smartpeg is excited by a magnetic pulse from the measurement tip 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 implant and is derived from the resonance frequency value obtained from the Smartpeg.
Ask a Question
K Number
K142358Device Name
Osstell IDx
Manufacturer
OSSTELL AB
Date Cleared
2015-02-19
(178 days)
Product Code
EKX
Regulation Number
872.4200Why did this record match?
Applicant Name (Manufacturer) :
OSSTELL AB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Osstell IDx is indicated for use in measuring the stability of implants in the oral cavity and maxillofacial region.
Device Description
The Osstell IDx is a modification of the Osstell ISQ (K082523). The system is designed to measure implant stability in the oral cavity and maxillofacial region. Similar to K082523, the Osstell IDx is a portable, handheld/tabletop instrument that involves the use of the noninvasive technique, Resonance Frequency Analysis. The system involves the use of a Smartpeg (aluminum rod) attached to the 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. The Osstell IDx 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.
Ask a Question
K Number
K132401Device Name
MEGA ISQ
Manufacturer
OSSTELL AB
Date Cleared
2014-04-09
(251 days)
Product Code
EKX
Regulation Number
872.4200Why did this record match?
Applicant Name (Manufacturer) :
OSSTELL AB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MEGA ISQ is indicated for use in measuring the stability of implants in the oral cavity and maxillofacial region.
Device Description
The MEGA ISQ is an new generation of the Osstell ISQ, (K082523) the system is designed to measure dental implant stability in the oral cavity and maxillofacial region. Similar to K082523, the MEGA ISQ is a portable, handheld instrument that involves the use of the noninvasive technique, Resonance Frequency Analysis. The 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.
Ask a Question
K Number
K082523Device Name
OSSTELL ISQ IMPLANT STABILITY METER
Manufacturer
OSSTELL AB
Date Cleared
2008-09-26
(24 days)
Product Code
EKX
Regulation Number
872.4200Why did this record match?
Applicant Name (Manufacturer) :
OSSTELL AB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Osstell® ISQ Implant Stability Meter is indicated for use in measuring the stability of implants in the oral cavity and craniofacial region.
Device Description
The Osstell® ISQ Implant Stability Meter is an updated version of the Osstell Mentor (K033689). The system is designed to measure dental implant stability in the oral cavity and craniofacial region. Similar to K033689, the Osstell ISQ is a portable, handheld instrument that involves the use of the noninvasive technique, Resonance Frequency Analysis. The 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.
Ask a Question
Page 1 of 1