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510(k) Data Aggregation
K Number
K091913Device Name
HI TECH IMPLANT, HT PHYSIO IMPLANT
Manufacturer
Date Cleared
2009-10-30
(122 days)
Product Code
Regulation Number
872.4200Why did this record match?
Applicant Name (Manufacturer) :
BY DENTAL SRL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Hi-Tech Implant/HT Physio Implant are intended to prepare Intraoral bone for implantology procedures.
Device Description
The HI TECH IMPLANT and HT PHYSIO IMPLANT consist of a microprocessor controlled unit, foot pedal, electric micromotor, support rods and sterile, disposable irrigation tubes. The unit also houses the peristaltic pump. The HI TECH IMPLANT and HT PHYSIO IMPLANT provide electronic control of velocity and torque. The HI TECH IMPLANT and HT PHYSIO IMPLANT can be programmed and retain programs into memory. The HI TECH IMPLANT and HT PHYSIO IMPLANT are fully operational from foot pedal.
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