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510(k) Data Aggregation
(252 days)
Dental air motor handpiece is intended for removing carious material, excess filling material, cavity and crown preparation, finishing tooth preparations and restorations, root canal preparations and polishing teeth.
Dental air motor handpiece is an instrument for drilling, grinding, repairing teeth that is utilized in dental clinics. It composed of handpiece and a connector, including low speed air motor, straight handpiece and geared angle handpiece. The subject device consists of 11 model variations:TM-203B2, TM-203M4, TM-205B2, TM-205M4, TM-IS, TM-ES, TM-SG20, TM-X25, TM-BB, TM-IC, TM-RA41. The device description of Dental air motor handpiece is as follows:
The gear ratios of handpieces have various gear ratios (for different geared angle handpiece);
Handpiece and adaptors can bear steam
The gear ratios of handpieces have a various gear ratio (for different geared angle handpiece) (1:1 (constant), 20:1 (speed reduction) and 4:1 (speed reduction));
The handpieces have maximum Forward rotation speed 24000rpm and maximum Reverse rotation speed of 24000 rpm.
The air motors are capable of running up to a speed of 24000 rpm, but can vary at different pressure of air supply.
Coupling is the accessory for handpiece to connect with tubes of dental unit. It could be divided into two types. It included 2-hole (drive air and water holes) and 4-hole coupling (drive air, exhaust air, spray air and spray water holes). The use of the coupling of handpiece is due to the number of tubes of dental unit.
The subject device is intended to be used for dental professional use only.
In order to avoid the risk, user must buy and use specified lubricant type "PANA SPRAY Plus" manufactured by NAKANISHI INC (cleared in K163483).
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