510(k) DEN230035
- Device
- DentalMonitoring
- Applicant
- Dental Monitoring Sas
- 510(k) number
- DEN230035
- Product code
- SBC
- Decision
- Unknown (DENG)
- Decision date
- 2024-05-17
- Date received
- 2023-05-04
- Regulation
- 872.1770
- Classification name
- Dental Image Analyzer
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Isabelle Puraye
- Address
- 75 Rue De Tocqueville Paris FR 75017 75017
FDA Registration Numbers#
- 3016367529
- 3014166037
Source Documents#
510(k) summary PDF not indicated by FDA