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