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510(k) Data Aggregation
K Number
K232440Device Name
Adravision Perio
Manufacturer
Date Cleared
2023-12-05
(113 days)
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
Adra Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Adravision Perio is a radiological semi-automated image processing software device intended to aid dental professionals in the measurements of mesial and distal bone levels associated with each tooth from bitewing and periapical radiographs. It should not be used in-lieu of full patient evaluation or solely relied upon to make or confirm a diagnosis.
The intended users of Adravision Perio are trained professionals including, but not limited to, dental hygienists.
The intended patient population of the device is patients living in the United States, who are 22 years old or older, and that do not have any remaining primary teeth. Adra Corporation has not evaluated the performance of the device on primary dentition.
Device Description
Adravision Perio is a Software as a Medical Device (SaMD intended to aid dentists in the measurement of mesial and dista bone levels associated with each tooth on bitewing and periapical dental radiographs of permanent teeth in patients 22 years of age or older.
The device provides assistance to dentists by suggesting the measurement of interproximal bone levels. The device recommendations are for reference only and the user should review associated radiographs, view annotations and modify annotations if needed. The device is not intended as a replacement for a complete clinician's review or their clinical judgment because users can take into account other relevant information from the image, intraoral exam or patient history.
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