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510(k) Data Aggregation
K Number
K111907Device Name
DYNAMIC DU SERIES PORTABLE DENTAL UNIT
Manufacturer
Date Cleared
2011-12-02
(150 days)
Product Code
Regulation Number
872.6640Why did this record match?
Applicant Name (Manufacturer) :
SHANGHAI DYNAMIC INDUSTRY CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The DU Series Portable Dental Unit is intended to supply power and serve as a base for dental devices and accessories. This device delivers air, water, vacuum, and electricity to handheld instruments, for use in dental clinics and hospitals. It is designed to be used by professional dental practitioners.
Device Description
1) The DU Series Portable Dental Unit is a combination of the speed handpieces, ultrasonic scaler, curing light, 3-way syringe, saliva ejector, clean water bottle, drain bottle, oil free air compressor, and footswitch.
2) The external AC power source provides electric power to the unit. The self contained air compressor provides air source to speed handpieces. The self contained water system provides water source for the syringe, handpieces and ultrasonic scaler.
3) The speed handpiece is supplied by the manufacturer of Predicate Device K991701; the ultrasonic scaler is supplied by K053555; the curing light is supplied by K080025. Other accessories are self-produced.
4) The patient contacting components are in the accessories of speed handpieces and the ultrasonic scaler. All the patient-contacting materials have passed biocompatibility testing according to ISO 7405:2008 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry.
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