Certifications

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Certifications

The FDA approval ( Sec. 872.3920 Porcelain tooth ), proves that the final product is safe, i.e. the ceramic crowns made by ceramic 3D printing are safe. This is the first FDA approval by AM (3D printing) in the category of Porcelain teeth.

It also indicates that the same materials using the same processes will be safe for other applications, for example Veneers and brackets for orthodontics.

FDA approval reference link: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K203072

Franz Biotech Inc. has successfully achieved ISO 13485 certification for its dental crown production, marking a significant milestone in quality and regulatory excellence. This accomplishment demonstrates the company’s commitment to maintaining the highest standards in medical device manufacturing, ensuring that its dental crowns meet strict safety, reliability, and compliance requirements. By adhering to ISO 13485, Franz Biotech Inc. enhances product consistency, strengthens risk management, and builds greater trust among customers and regulatory bodies. This certification reinforces the company’s dedication to continuous improvement and positions it as a leader in the dental industry, offering high-quality, precision-crafted dental solutions.

GMP Certificate: This certifies Franz 3D Printing Technology and GMP process has been inspected by the Ministry of Health and Welfare and found to be compliance with the medical device Good Manufacturing Practice (GMP) requirements (based on ISO 13485)

TFDA Porcelain crowns(2020) and Veneer(2021), class II