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510(k) Data Aggregation
K Number
K120218Device Name
TEK USA E-GENERATOR INTEGRATED LED HANDPIECE (HIGH & LOW SPEED AIR TURBNINE DENTAL HANDPIECE)
Manufacturer
Date Cleared
2012-06-29
(156 days)
Product Code
Regulation Number
872.4200Why did this record match?
Applicant Name (Manufacturer) :
PALM BEACH DENTAL SUPPLY D/B/A TEK USA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The TEK USA Airdriven LED handpiece with Integrated E-Generator is indicated for use by a trained dental professional authorized in the practice of general dentistry. These dental handpiece devices are available in both high and low speed and are designed for removing carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations/restorations, polishing teeth and other procedures that are considered within the space of dental prophylaxis.
Device Description
TEK USA Airdriven LED Handpiece with Integrated E- generator
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