FDA.reportPublic FDA data

De Novo DEN230035

Device
DentalMonitoring
Contact
isabelle puraye
De Novo number
DEN230035
Product code
SBC
Regulation
872.1770
Classification name
dental image analyzer
Decision
granted (DENG)
Decision date
2024-05-17
Date received
2023-05-04
Classification advisory
Dental
Review advisory
Dental
Type
Direct

Current FDA Classification#

Product code
SBC
Device name
Dental Image Analyzer
Medical specialty
Dental
Device class
2
Regulation
872.1770
Implant
N
Life sustain/support
N