The classification of dental products includes categories such as restorative materials, denture fabrication materials, orthodontic materials and products, etc. The conditions that need to be met for exporting dental products to the U.S. include UL certification, FCC certification, FDA certification, etc.
The classification of dental products:
- Restorative Materials:
- Such as composite resins, cement powder, enamel bonding agents, etc., used for the repair and beautification of teeth.
- Denture Fabrication Materials:
- Including metal and ceramic materials made into crowns, bridges, dentures, etc., these materials usually need to have good biocompatibility and aesthetics.
- Orthodontic Materials and Products:
- Such as various orthodontic archwires, brackets, invisible correctors, etc., used for orthodontic treatment of teeth.
- Oral Implantation and Tissue Reconstruction Materials:
- Including implants, bone substitutes, etc., used for the repair and reconstruction of tissue defects in the mouth.
- Adjunctive Materials for Oral Treatment:
- Such as various oral cleaners, anesthetics, hemostatic agents, etc., used for adjunctive purposes during oral treatment.
Conditions Needed to Be Met for Export to the U.S.:
- UL Certification:
- To verify the safety and compliance of the product, ensuring the safety of the dental product during use.
- FCC Certification:
- For dental products with electronic functions, such as electric toothbrushes, oral scanners, etc., to ensure their electromagnetic compatibility.
- FDA Certification:
- Almost all dental products need to undergo FDA certification to prove their safety and effectiveness as medical devices.
- EPA Certification:
- If the dental product involves chemicals or disinfectants, EPA certification is needed to ensure its safety to the environment and human body.
- CPSC Certification:
- To ensure that dental products meet the safety standards of consumer products in the United States, such as children’s toothpaste and other consumer products.
