BEGO’s Permanent Restorative 3D Printing Hybrid Resin Approved by NMPA for Launch in China

Source: BEGO official website

DentalGoodNews｜Recently, BEGO's 3D printing hybrid resin VarseoSmile® Crown plus received approval from the National Medical Products Administration, with registration certificate number GuoxiezhuJin 20263170356.

Source: National Medical Products Administration

According to National Medical Products Administration information, the product's approved scope of use in China is for the fabrication of permanent single Dental Crowns and veneers through light-curing 3D Printing processes. Data from BEGO's official website shows that its flexural strength is 116–150 MPa, flexural modulus is 4090 MPa, Shore hardness (Type D) is no less than 90, inorganic fillers account for 30%–50% by mass, and it is available in 7 VITA classic shades and 1 bleach shade.

Regarding equipment compatibility, BEGO states that the material has been validated on multiple 3D printers in China and overseas, and laboratories and clinics with digital workflows can adopt it without changing equipment. In practice, light curing can use BEGO Otoflash or HiLite Power; preparation margins need to be clearly visible, the minimum wall thickness of the restoration is 1 mm, and concave or stepped preparations are recommended; for bonding, commercially available self-adhesive Resin Cement may be used, or Resin Cement used with a primer, subject to the instructions of the selected adhesive.

Overseas, BEGO states that the product has received U.S. FDA 510(k) clearance (Class II Medical Devices) and complies with the requirements for Class IIa products under EU MDR.