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510(k) Data Aggregation
K Number
K141886Device Name
MDK HANDPIECES
Manufacturer
MODERN KOREA CO., LTD.
Date Cleared
2015-05-13
(303 days)
Product Code
EFB
Regulation Number
872.4200Why did this record match?
Applicant Name (Manufacturer) :
MODERN KOREA CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
MDK high-speed handpieces are used for the removal of carious material, reducing of hard tooth structure, cavity and crown preparations, removal of fillings, processing and finishing tooth preparations, and for polishing teeth. MDK low-speed handpieces used for teeth cutting, cavity and crown preparations and polishing teeth. All the devices are designed for use by a trained professional in the field of general dentistry.
Device Description
The MDK handpieces are dental hand pieces for use by a trained professional in the field of general dentistry. They are air-powered handpieces that are reusable and have a fiber optic light system (some models do not have this feature.). The MDK handpieces are supplied with water, air and light through the tube and dental treatment units. The MDK handpieces offer high-speed handpieces and low-speed handpieces according to rpm. The high-speed handpieces with fiber optic have 11 models and those without fiber optic have 10 models. The low-speed handpieces are divided into 3 types: contra angle handpieces provided with and without a fiber optic light system, and straight handpieces. The contra angle handpieces with fiber optic have 4 models and those without fiber optic have 10 models. The straight handpieces have 2 models. The MDK handpieces are hand-held, channeled instruments that are powered by compressed air delivered through a hose to an air channel in the handpieces. This impels the turbine in the head of the handpiece to revolve. The bur of the high speed handpieces can rotate up to 400,000 rpm and the bur of the low speed handpieces can rotate up to 100,000 rpm. Dental burs (not part of this 510k) can be inserted into the chuck system of each handpiece (push button, latch, screw, snap-on or tip-lock chuck options). The low-speed handpieces are used with the air motors (20.000 rpm) made by our company and offer various gear ratio (1:1(constant), 20:1(speed reduction), 30:1(speed reduction), and 1:5(speed increase)). The high-speed handpieces are used with the following compatible couplings made by the third party manufacturers. The headpieces are made of titanium and stainless steel, and must be cleaned and sterilized between use by the user.
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