Devices · Dental Monitoring SAS

DentalMonitoring

Dental Monitoring SAS is listed for DentalMonitoring (DEN230035). The FDA list gives May 17, 2024 as the date of the final decision. The lead panel is Dental, and the database link on the FDA list is the De Novo pathway. openFDA describes product code SBC as “Dental Image Analyzer”: A dental image analyzer is a prescription home use device that uses software intended to collect and analyze patient-specific, optical camera-based, intraoral images. The analyses are provided to dental health care professionals as an aid to diagnosis of oral health conditions and/or to monitor treatment progress. openFDA records this submission’s decision description as “Unknown.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN230035

Official FDA database record

Date of final decision

May 17, 2024

Company on the FDA list

Dental Monitoring SAS

Lead panel

Dental

Primary product code

SBC

openFDA device name for the code

Dental Image Analyzer

Device class

2

Regulation number

872.1770

openFDA decision description

Unknown

openFDA decision code

DENG

Statement or summary label

Not returned