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510(k) Data Aggregation
K Number
K063302Device Name
SDIF DENTAL CHAIR WITH OPERATIVE UNIT AND ACCESSORIES
Manufacturer
Date Cleared
2006-11-15
(14 days)
Product Code
Regulation Number
872.6640Why did this record match?
Applicant Name (Manufacturer) :
SHANGHAI DENTAL INSTRUMENT FACTORY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
SDIF Dental chairs with operative unit is indicated for use to supply power to and serve as a base for dental devices and accessories. This product includes a dental chair. The unit is indicated for use in the dental clinic/office environment used by trained dentists and/or dental technicians and assistants
Device Description
SDIF dental chairs with operative units provide patient comfort and dentists' air and water supplies for dental instruments and procedures. Water pressure: 200~400Kpa. Air water Supplios for dontar mounts can be powered from ~110/220/230V. The chair is protoure. The system is compatible with instruments from various manufacturers with standard fittings.
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K Number
K063110Device Name
CST61 HIGH SPEED TURBINE HANDPIECE
Manufacturer
Date Cleared
2006-10-26
(15 days)
Product Code
Regulation Number
872.4200Why did this record match?
Applicant Name (Manufacturer) :
SHANGHAI DENTAL INSTRUMENT FACTORY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
CST61 High Speed Turbine Handpiece is indicated for use intra and extra orally to cut, shape, grind and polish teeth, or items related to teeth and dental devices that may be in the mouth or to be placed in the mouth
Device Description
CST61 high speed turbine handpiece is an air-powered, hand-held device for use as an operative dental unit accessory at 250KPa with rotation speed of 250,000 RPM in order to perform cutting, shaping, grinding, and polishing functions.
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