Compliance and regulation are at the core of Hundredjack’s differentiation.
In a market crowded with unsafe, unregulated direct-to-consumer products, we position ourselves as the certified, traceable, and legally compliant standard.
This section describes how we align with EU and international requirements, ensuring that every product carrying the Hundredjack brand meets the strictest safety and legal expectations.
CE Marking (Medical Devices)
Ensures all products meet EU safety, health, and environmental protection requirements.
GDPR (General Data Protection Regulation)
Governs how patient and customer data is collected, stored, and processed across the ecosystem.
ISO Standards (Lite Approach)
Adoption of ISO 13485 principles (medical devices QMS) adapted to our product categories.
Local Medical Regulations
Compliance with each country’s dental and medical authority requirements (Italy, Estonia, later Germany/EU).
Certified Materials Only: Dreve thermoplastics, validated metals and stones, biocompatible resins.
Traceability: Every product is logged with full audit trail — materials, lab, production steps, dentist.
Conformity Declarations: Labs issue documentation for every piece, ensuring legal and medical compliance.
Dentra & SaaS are designed with GDPR-first principles:
Consent collection.
Secure storage.
Role-based access to sensitive data.
Audit-Ready Logs: Every workflow step is documented for regulatory inspections.
Defensive Moat: Regulation is raising barriers. Unsafe DTC sellers will not survive.
Trust Factor: Dentists and patients are more likely to adopt a system that is legally and clinically safe.
Scalability: Compliance embedded at the start avoids costly retrofits when expanding across EU markets.