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510(k) Data Aggregation
K Number
K051872Device Name
MK-DENT LOW SPEED HANDPIECES AND ACCESSORIES INCLUDING SPARE PARTS, TUBINGS, AND LIGHT POWER SYSTEM, MODELS: LS2011
Manufacturer
MK-DENT GMBH
Date Cleared
2005-10-03
(84 days)
Product Code
EFB
Regulation Number
872.4200Why did this record match?
Applicant Name (Manufacturer) :
MK-DENT GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MK-dent® Low Speed Handpieces are dental handpieces for use by a trained professional in general dentistry.
Device Description
The MK-dent® Low Speed Handpieces are compatible to air and electric drives. The handpieces are available in several versions. For example, the LS 2011L is an angled handpiece providing light through a glass optic rod, the LS 2001 has no glass optic rod, and the LS1011 is non-angled.
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K Number
K032234Device Name
MK-DENT HIGH SPEED DENTAL HANDPIECE, MODELS HS 4021K, 4011K, 4012K, AND HS 6021K, 6011K, 6012K
Manufacturer
MK-DENT GMBH
Date Cleared
2003-10-02
(73 days)
Product Code
EFB
Regulation Number
872.4200Why did this record match?
Applicant Name (Manufacturer) :
MK-DENT GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device is an air-powered dental handpiece providing light through a glass optic rod for use by a trained professional in general dentistry.
Device Description
The MK-dent® HS Handpiece shares virtually all specifications and design characteristics of the predicate devices. This was done intentionally by the designers and engineers. Only few minor changes implemented to the predicate device make the MKdent® Handpiece more convenient to use but do not affect the performance, safety or effectiveness of it.
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