2023 Jul 25

SA-260MA & SA-260MA-R autoclaves obtained the FDA 510(k) !

We are excited to announce that the SA-260MA and SA-260MA-R autoclaves have obtained FDA 510(k)!

The SA-260MA and SA-260MA-R autoclaves have been rigorously reviewed by the U.S. FDA for safety, performance and functionality under the intended use in accordance with the substantially equivalent.

Following valuable feedback from the market, the autoclaves have been completely upgraded. While retaining its original advantages, we have shorten the total cycle time and fitted with additional filling water funnel while keeping efficient and reliable sterilization performance to provide your medical and dental practice with a superior, safe autoclave.

Thank you for your continuous support and trust! We will persistently strive to bring you more innovative products, solidifying our position as your most reliable sterilization partner.

510(k) Number : K231489

LINK: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231489