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510(k) Data Aggregation
K Number
K092833Device Name
ENDOMAX CORDLESS ENDODONTIC HANDPIECE
Manufacturer
DENTAMERICA
Date Cleared
2010-01-07
(114 days)
Product Code
EKX
Regulation Number
872.4200Why did this record match?
Applicant Name (Manufacturer) :
DENTAMERICA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Endomax™ is a cordless handpiece used primarily for root canal enlargement. This application area extends to endodontic procedures using a root canal instrument which is intended by the manufacturer for use in the mechanical and rotary preparation of root canals.
Device Description
The Endomax" Cordless Endodontic Handpiece has a number of substantially equivalent (SE) predicate devices. These predicate devices use the same technological methods to perform mechanical and rotary preparation of root canals with a cordless handpiece. A modular electrical system consisting of a drive handpiece, a rechargeable battery, contraangle head and a charging station are the main components of the predicate devices. The materials used in this device are composed of brass, silicon and Type II plastic as in the substantially equivalent devices.
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K Number
K060640Device Name
DIGIREX DIGITAL DENTAL RADIOGRAPHY SYSTEM
Manufacturer
DENTAMERICA
Date Cleared
2006-04-24
(45 days)
Product Code
EHD
Regulation Number
872.1800Why did this record match?
Applicant Name (Manufacturer) :
DENTAMERICA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Digirex™ Digital Dental Radiography System replaces the traditional film approach to x-ray imaging. A digital sensor rather than film is used to capture x-rays from an external source and produce digital images of a patient's mouth. The digital sensor and the USB controller allow the images to be transferred to a computer for analysis, archiving and electronic transmission.
Device Description
The Digirex™ Digital Dental Radiography System replaces the traditional film approach to x-ray imaging. A digital sensor rather than film is used to capture x-rays from an external source and produce digital images of a patient's mouth. The digital sensor and the USB controller allow the images to be transferred to a computer for analysis, archiving and electronic transmission.
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K Number
K954820Device Name
SCALEX 800
Manufacturer
DENTAMERICA
Date Cleared
1996-01-18
(90 days)
Product Code
ELC
Regulation Number
872.4850Why did this record match?
Applicant Name (Manufacturer) :
DENTAMERICA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K955759Device Name
LITEX 680
Manufacturer
DENTAMERICA
Date Cleared
1996-01-02
(15 days)
Product Code
EBZ
Regulation Number
872.6070Why did this record match?
Applicant Name (Manufacturer) :
DENTAMERICA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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