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510(k) Data Aggregation
K Number
K021250Device Name
MK-DENT PUSH BUTTON HIGHSPEED HANDPIECE, 4 HOLES, MODELS HS 2012 (STANDARD HEAD) & HS 2014 (SMALL HEAD)
Manufacturer
Date Cleared
2002-10-24
(188 days)
Product Code
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
HANDPIECE UNLIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The device is an air-powered dental handpiece for use by a trained professional in general dentistry.
Device Description
The MK-dent® HS 2012/2014 shares virtually all specifications and design characteristics of the predicate devices. The only major design change refers to the strength of the auto chuck mechanism. By increasing the spring strength, we have created a more reliable version compared to KaVo 625. By increasing the bur retention strength from 6 lbs (as with the predicate device) to 8 lbs. (MK-dent® HS 2012/2014) we have been able to vastly reduce the odds of a bur prematurely ejecting from the handpiece. A few minor changes to the predicate device which do not affect the performance but we feel make the handpiece convenient to use are as follows: Reduction in the weight of the handpiece to 2 oz.. This reduces operator hand fatigue. Softening the knurling on the handle. This allows dirt, blood and salvia to be more easily removed from the body shell of the handpiece, thus allowing better conformity to sterilization procedures. It also provides better tactile sense to the operator while wearing gloves.
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