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510(k) Data Aggregation
K Number
K063646Device Name
OPTI
Manufacturer
Date Cleared
2007-03-07
(90 days)
Product Code
Regulation Number
872.6640Why did this record match?
Applicant Name (Manufacturer) :
CAMSIGHT CO., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The intraoral camera system, Opti, of CamSight Co., 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 mouth showing the patient results of the dental procedures which the dentist has performed on him.
Device Description
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K Number
K053221Device Name
CDMX-H
Manufacturer
Date Cleared
2006-01-12
(56 days)
Product Code
Regulation Number
872.1800Why did this record match?
Applicant Name (Manufacturer) :
CAMSIGHT CO., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The CDMx-H is intended for dental radiographic examination and diagnosis of the teeth, jaw and oral structure by using scanned dental x-ray images sent through the digital x-ray sensor.
Device Description
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K Number
K010915Device Name
CDMX
Manufacturer
Date Cleared
2001-05-21
(55 days)
Product Code
Regulation Number
872.1800Why did this record match?
Applicant Name (Manufacturer) :
CAMSIGHT CO., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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