Quality Standards & Regulatory Compliance
At TOV Implant, quality is more than a commitment—it is the foundation of everything we manufacture.
Every implant, prosthetic component, and surgical instrument is designed, manufactured, and inspected according to the highest international standards to ensure safety, reliability, precision, and long-term clinical success.
International Certifications
TOV Implant operates under a comprehensive Quality Management System certified according to ISO 13485:2016, the internationally recognized standard for medical device manufacturing.
Our implant systems are CE Certified and FDA Cleared (510(k) K240837), demonstrating compliance with stringent regulatory requirements and our commitment to delivering safe and effective implant solutions to dental professionals worldwide.
Our Certifications
✔ ISO 13485:2016 Certified Quality Management System
✔ CE Certified Medical Devices
✔ FDA 510(k) Cleared – K240837
✔ Full Lot Traceability
✔ Validated Sterilization Processes
✔ Medical Grade Titanium Manufacturing
Complete Traceability
Every TOV Implant product is assigned a unique lot number, ensuring complete traceability throughout the entire manufacturing lifecycle.
All incoming raw materials undergo rigorous inspection and verification before entering production. Detailed records are maintained at every stage of manufacturing, allowing full monitoring and quality assurance from raw material sourcing to final product delivery.
Precision Manufacturing
Our implants are manufactured from high-quality medical-grade titanium using advanced CNC machining technologies and tightly controlled production processes.
Strict dimensional inspections and quality control procedures are performed throughout manufacturing to ensure exceptional precision, consistency, and mechanical reliability.
Each product is manufactured to meet the demanding requirements of modern implant dentistry and provide clinicians with predictable and reproducible outcomes.
Sterility & Patient Safety
Patient safety remains our highest priority.
All sterile products undergo validated sterilization procedures and comprehensive quality verification before release. Every production batch is subjected to rigorous testing and inspection protocols to ensure compliance with the highest standards of safety and performance.
Continuous Quality Assurance
Quality control is integrated into every stage of our operations.
From design and development to manufacturing, packaging, and distribution, our quality teams continuously monitor processes to ensure product consistency, reliability, and regulatory compliance.
Our commitment to continuous improvement drives ongoing investments in manufacturing technologies, quality assurance systems, product validation, and regulatory excellence.
Commitment to Clinical Excellence
Dental professionals trust TOV Implant because our products are developed with a single objective: delivering reliable, predictable, and long-lasting clinical outcomes.
By combining advanced manufacturing, rigorous quality controls, international certifications, and regulatory compliance, TOV Implant provides clinicians worldwide with implant solutions they can use with confidence.
TOV Implant — Precision Engineered. Clinically Trusted. Globally Certified.