- Introduction: A New Era of Dental Engineering & AI Education
On September 4, 2025, First Lady Melania Trump hosted the White House Task Force on Artificial Intelligence Education, reaffirming that AI education, workforce readiness, and responsible innovation are national priorities. The White House She said:
“We must manage AI’s growth responsibly. During this primitive stage, it is our duty to treat AI as we would our own children — empowering, but with watchful guidance.” The White House
MYDENTALWIG’s Smile Engineering Academy (SEA) is our response. While many institutions focus on clinical dental training under state dental boards, the engineering and manufacturing side of dentistry—biosensor design, chip fabrication, clean‑room process engineering—remains under‑represented and largely offshored. SEA is built to fill this gap with AI dental chip innovation, federal regulatory compliance, and owned intellectual property.
- The Dream Becomes Reality: Lydie Livolsi’s Vision & SEA’s Mission
Since 1987, Lydie Livolsi has dreamt of raising the standards in dental manufacturing. After three years in a private dental manufacturing school in Aix‑en‑Provence, two years in Nancy, and one year at UFR of Odontology in Reims, she saw firsthand how dental lab tech and manufacturing were undervalued. Today, SEA embodies that lifelong passion. Unlike clinical education governed by state dental boards, SEA trains engineers, innovators, and makers whose work is regulated by the federal system (FDA). We own our innovations—including our patented AI dental chip (projected output: 4 million high‑end biosensors and 2 million chips annually)—and every core R&D advance will remain in‑house.
- What Sets SEA Apart: Engineering, Ownership & Federal Oversight
- Engineering & Manufacturing First
SEA is not about clinical practice. It trains engineers, materials scientists, and production experts to design and manufacture medical‑device grade dental devices, biosensors, and AI chips—with precision, scale, and quality. - In‑House Innovation & Proprietary IP
All core R&D, patent filing, design, chip fabrication, and biosensor development are owned by MYDENTALWIG. We are not outsourcing our core technologies; we are building them. - AI Integration & Diagnostic Precision
AI is integrated from day one: machine learning for defect detection; predictive analytics in processes; sensor fusion; optimizing yield and reliability through smart QA. - Regulatory Leadership Under FDA
SEA operates under the federal regulatory framework, not state dental boards. The FDA’s recent final rule, known as the Quality Management System Regulation (QMSR), updates 21 CFR Part 820 (formerly Quality System Regulation, QSR) to align with ISO 13485:2016. Enforcement begins February 2, 2026. U.S. Food and Drug Administration+2AAMI Array+2 - Production Scale & Clean‑Room Excellence
Students will work in real clean‑rooms, with chip fabrication, biosensor labs, precision tooling, and full production workflows. Not just workshops; production‑scale, FDA‑compliant, clean‑room engineering.
- Curriculum & Capabilities: AI, Biosensors, Clean Rooms, Innovation Labs
- Foundations in Engineering & AI Health Tech
Materials science (metals, ceramics, polymers), micro‑/nano‑fabrication, AI & ML fundamentals, data analytics. - Clean‑Room & Production Engineering
ISO 14644 clean‑room protocols, lithography, sensor etching, tooling calibration, yield and throughput optimization. - Regulatory & Compliance Education
Device classification, FDA registration, premarket/510(k)/PMA pathways, Good Manufacturing Practice (GMP) & QMSR compliance under 21 CFR Part 820. Continuous training in documentation, labeling, safety. - AI & Biosensor Innovation Lab
Prototyping, signal processing, defect detection, sensor integration, biocompatibility, longevity testing. Innovation challenges, labs that mimic real production. - Hands‑On Apprenticeship & Production Integration
Internships and on‑site training within MYDENTALWIG manufacturing facilities; students participate in real production runs, quality audits, process validation.
- Regulatory Clarity: State vs Federal Oversight
- State Dental Boards regulate clinical practice: licensing dentists, hygienists, assistants. These boards oversee patient care, clinical rules, but do not regulate manufacturing or device fabrication.
- FDA / Federal Regulation covers medical device manufacturing. Clean‑room production, biosensors, chips, implants, device safety, labeling, efficacy—all fall under federal law: 21 CFR Part 820 / QMSR, Food Drug & Cosmetic Act, related regulations. SEA ensures full compliance.
- Policy Alignment & National Priorities in AI Education
The White House Task Force on AI Education, launched by the April 2025 Executive Order Advancing Artificial Intelligence Education for American Youth, defines key goals: AI literacy, public‑private partnerships, AI training and innovation for students and educators. The White House+2The White House+2
SEA aligns with this national momentum by providing medical device education, precision engineering labs, AI innovation, and federal device manufacturing training. As over 135+ private sector pledges have been made in support of AI education, SEA is positioned as part of the next wave of leadership. The White House
- Regulatory & Quality System Update: FDA’s QMSR Final Rule
Understanding FDA’s regulatory changes is essential for SEA:
- On January 31, 2024, the FDA issued its final rule amending the device current good manufacturing practice requirements under 21 CFR Part 820, re‑named QMSR, to incorporate ISO 13485:2016. AAMI Array+3U.S. Food and Drug Administration+3AABB+3
- The effective date is February 2, 2026. Until then, manufacturers must comply with existing QS Regulation. After that, QMSR requirements will be enforced. U.S. Food and Drug Administration+1
- Key goals: harmonization with global standards, clarity of definitions, more robust quality management systems. These are central for SEA’s curriculum, labs, manufacturing workflow, and students’ training.
- Challenges & How SEA Plans to Overcome Them
- Faculty & Staff Recruitment: Need experts in medical device engineering, AI, biosensors, FDA regulatory affairs. Solution: Recruiting globally, competitive compensation, leveraging advisors.
- Infrastructure Costs: Clean‑rooms, precision fabrication tools, quality assurance systems are expensive. Solution: Modular design, phased build, strategically prioritized investments.
- Regulatory Complexity: Classification, premarket submissions, post‑market monitoring. Solution: Internal regulatory affairs teams, external advisory, curriculum that trains in documentation and compliance.
- Scaling Innovation & Quality: Maintaining yield, minimizing defects, ensuring reproducibility. Solution: Strong QA/QC processes, AI‑driven defect detection, process optimization, real‑time monitoring.
- Why It Matters: Innovation, Domestic Manufacturing, Economic Impact
- Elevating dental lab techs and engineering professionals into high‑skill, high‑value roles.
- Reducing dependency on overseas sources for crowns, bridges, chips, biosensors—keeping value chain domestic.
- Ownership of IP: producing medical‑device grade AI dental chips, biosensors; boosting U.S. leadership in health tech.
- Economic growth: quality jobs, technical training, innovation in clean‑room manufacturing, medical device regulation.
- Call to Action: Join SEA’s Vision
MYDENTALWIG invites:
- Investors who believe in AI health tech, federal compliance, medical device manufacturing, biosensor engineering.
- Regulatory & Device Engineering Experts to join SEA as advisors, instructors, or collaborators.
- Aspiring Engineers & Technicians who are excited about clean‑room engineering, AI‑powered chip design, precision manufacturing, and regulatory innovation.
SEA is not just an academy. It is a movement—to raise standards, own innovation, and build the future.
Conclusion: Engineering the Future of Dental Health Tech
With the national spotlight on AI education, federal device manufacturing standards (including the FDA’s QMSR aligning with ISO 13485:2016), and growing need for advanced dental engineering, the moment is right. SEA (Smile Engineering Academy) of MYDENTALWIG will pioneer what dentistry engineering means. From Lydie Livolsi’s early studies in France to patented AI dental chips, SEA stands ready: Engineering the future.