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510(k) Data Aggregation
K Number
K993188Device Name
ENDOSTEPPER 1
Manufacturer
Date Cleared
1999-09-28
(5 days)
Product Code
Regulation Number
872.4200Why did this record match?
Applicant Name (Manufacturer) :
PHYTRON- ELEKTRONIK GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
To be used for dental drilling and other dental drive applications.
Device Description
The EndoStepper System is an electronically controlled drive for dental drilling applications. The system consists of (1) a console type housing containing the electronics with a LCD display and a keypad, (2) a foot pedal unit, (3) a drive unit to be used with (4) a protective cover and a commercially available contraangle.
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