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510(k) Data Aggregation
K Number
K062947Device Name
HIGH SPEED AIR TURBINE HANDPIECE, MODELS SUPER-AIR AND SUPER-QD SERIES
Manufacturer
PENG LIM ENTERPRISE CO., LTD.
Date Cleared
2006-12-14
(77 days)
Product Code
EFB
Regulation Number
872.4200Why did this record match?
Applicant Name (Manufacturer) :
PENG LIM ENTERPRISE CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PENG LIM High Speed Air Turbine Handpieces are intended for removing carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations and restorations and polishing teeth.
Device Description
Dental Air-Powered Handpiece
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K Number
K061695Device Name
LED PROLUX 770
Manufacturer
PENG LIM ENTERPRISE CO., LTD.
Date Cleared
2006-09-14
(91 days)
Product Code
EBZ
Regulation Number
872.6070Why did this record match?
Applicant Name (Manufacturer) :
PENG LIM ENTERPRISE CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This LED Prolux 770 is a visible curing unit designed for polymerization of light cured materials used by dental professionals.
Device Description
This LED Prolux 770 is a visible curing unit designed for polymerization of light cured materials used by dental professionals.
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