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510(k) Data Aggregation
K Number
K101551Device Name
PACEMAKER HIGH-SPEED HANDPIECE MODEL PM-MQ, PM-M
Manufacturer
Date Cleared
2010-09-09
(97 days)
Product Code
Regulation Number
872.4200Why did this record match?
Applicant Name (Manufacturer) :
DELMA MEDICAL INSTRUMENT (GUANGZHOU) CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
PACEMAKER High-Speed Handpiece, models PM-MQ and PM-M are intended for removing carious material, reducing hard tooth structure, cavity prepardtion, finishing tooth preparations and restorations and polishing teeth.
Device Description
The PACEMAKER High-Speed Handpiece is a high speed dental handpiece with a lightly textured finish for enhanced grip. It is a hand-held, channeled instrument that is powered by compressed air that is delivered through a hose to an air channel in the handpiece. This impels the turbine in the head of the handpiece to revolve. Other internal channels deliver air and water to the head for cleaning and cooling. Any common dental bur is held in place in the handpiece head by a pushbutton.
There are three major parts which are made metal: a standard turbine, the threaded connector at the back end which attaches to the standard air/water hose in the dental unit, and the internal tubes that carry the chip air and water. These three parts are substantially equivalent to those in the predicate device.
Similar to the predicate device, the PACEMAKER High-Speed Handpiece must be cleaned and lubricated with a quality commercial dental handpiece cleaner/lubricant. It is supplied non-sterile, but must be sterilized before use, as with the predicate device. It will be packaged as a single unit or in multiples.
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