Regulatory & Compliance
Neordent is building GentleDental.ai with a wellness-first positioning while preparing for future medical-grade expansion. Today, the Gentle AI Smart Toothbrush and GentleDental.ai platform are designed for preventive and wellness use, not as diagnostic medical devices.
Regulatory Roadmap
We are designing our hardware and software stack with a clear regulatory pathway in mind:
DPIIT Recognition
DPIIT-recognized startup in healthcare technology
CDSCO Pathway
Planned regulatory pathway for medical device signaling in India
FDA Roadmap
Planned FDA pathway for entry into international health markets
Specific regulatory designations and approvals will be reflected as they are obtained.
Data Privacy & Security
We are committed to strong data privacy and security for all user and health-related data.
Secure Imaging
Secure handling of oral images and PPG-derived features using advanced encryption and proprietary storage protocols.
Privacy-by-Design
Privacy-by-design principles deeply integrated into our data architecture to ensure user anonymity and control.
Standards Alignment
Alignment with global health data and privacy standards (including HIPAA/GDPR readiness) as our platform scales internationally.
Disclaimers
All descriptions of product capabilities and wellness insights are for informational purposes only and do not constitute medical advice, diagnosis, or treatment. GentleDental.ai is currently positioned as a wellness product. Any future medical-grade indications will be explicitly labeled once appropriate regulatory approvals are obtained.