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510(k) Data Aggregation
K Number
K033597Device Name
ATR 5000, LC 5000, IMPLANT SYSTEM
Manufacturer
ADVANCED TECHNOLOGY RESEARCH (A.T.R.) S.R.L.
Date Cleared
2003-11-25
(11 days)
Product Code
EKX
Regulation Number
872.4200Why did this record match?
Applicant Name (Manufacturer) :
ADVANCED TECHNOLOGY RESEARCH (A.T.R.) S.R.L.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
These ATR Surgical Micromotors are intended to prepare Intraoral bone for implantology procedures.
Device Description
The ATR Surgical Micromotors ATR5000, LC5000 and Implant System, are microprocessor driven surgical micromotors used in implantology procedures. The ATR Surgical Micromotors ATR5000, LC5000 and Implant System consists of a microprocessor controlled unit, foot pedal, electric micromotor, support rods and sterile, disposable irrigation tubes. The units also house the peristaltic pump. The ATR Surgical Micromotors ATR5000, LC5000 and Implant System provide electronic control of velocity and torque. The ATR Surgical Micromotors ATR5000, LC5000 and Implant System can be programmed and retain programs in memory. The ATR Surgical Micromotors ATR5000, LC5000 and Implant System are fully operational from foot pedal.
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