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510(k) Data Aggregation
K Number
K013690Device Name
IDENT-A100 INTRAORAL VIDEO CAMERA
Manufacturer
Date Cleared
2002-01-30
(84 days)
Product Code
Regulation Number
872.6640Why did this record match?
Applicant Name (Manufacturer) :
CONFIDENT TECHNOLOGY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The iDENT-A100 Intraoral video camera of the Confident Technology Inc. is used to provide a view of the mouth in order to assist the dentist in describing dental procedures and to show a patient before and after views of his/her mouth showing the patient results of the dental procedures which the dentist has performed on him/her. These are not intended to aid in dental surgical procedures.
Device Description
The iDENT-A100 Intraoral Video Camera provides clear, high resolution images of the oral cavity, which can be stored and manipulated in the built digital memory and used for visual communication directly to the patient. The System can capture one full image or can capture four images into one frame and the captured images can be display on a video monitor. The operation of the capturing image can be done by a foot switch or a push button and is very user-friendly. The typical dentist and assistant can use the system with a few minutes training.
A high resolution, true color image is produced on the screen by a rod lens scope design which is the standard in the industry for endoscopic procedures. There is no peripheral distortion of the image. Manual focusing is not required and a single tooth or full arch view can be captured without changing the scope. The unit is easily detached for autoclaving cleaning.
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