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510(k) Data Aggregation
K Number
K143445Device Name
Tellos ISQ Buddy
Manufacturer
Tellos Medical AB
Date Cleared
2016-01-07
(401 days)
Product Code
EKX
Regulation Number
872.4200Why did this record match?
Applicant Name (Manufacturer) :
Tellos Medical AB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Tellos ISQ Buddy is indicated for use in measuring the stability of dental implants in the maxillofacial region.
Device Description
The Tellos ISQ Buddy measurement system consists of: Tellos ISQ Buddy Instrument (Hand-held instrument), ISQ Peg Driver (Driver to attach the ISQ peg to the implant), Tellos ISQ Buddy Charger (100-240 VAC to 5VDC charger for the instrument batteries), and ISQ Peg (Measurement pin to attach to the implant. Different pins are available to fit different implant types.). The instrument is a hand-held, battery-driven device for measuring the relative stability of a dental implant. A small pin "ISQ peg" is attached to the dental implant by a screw-connection, with the Peg Driver. The pin has a small magnet incorporated into its top. The instrument is held towards the ISQ Peg, and sends short magnetic pulses that bring the pin into vibration. After a pulse has been sent, the instrument measures the vibration by sampling the signal from the alternating magnetic field that follows from the vibrating pin. The frequency of the signal is determined by the instrument and is presented as an "ISQvalue", 1 to 100, where a higher number means higher stability. The measurement takes about 1 second. The instrument consists of a microcontroller and circuits to send the magnetic pulses, to receive the measurement signal, and to present the measurement value. A circuit for battery-charging is also included. Two 2-digit LED displays, one on each side of the instrument, show the measurement value and also communicate possible error codes and software id number at start-up. One operating key is used to turn the instrument on and off. The electronics are contained in a plastic body, which is sealed except for the instrument which has a charging connector. The plastic body is made from PC/ABS plastic except for the tip, which is made from PEEK. No part of the instrument is intended to contact the patient; however there can be unintentional contact with the tip of the instrument. The instrument is battery-driven and contains re-chargeable NiMh-batteries can be charged during use, but it should not be attached while measuring due to the risk of power line interference making it impossible to measure. For safety, a charger complying with IEC 60601-1 is used. The charger connector is of a type that does not allow other chargers to be connected, thereby eliminating the risk of the wrong charger being used.
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