On June 17, 2025, VCS Medical announced that its innovative dental product DentalJect™ has officially received 510(k) clearance from the U.S. Food and Drug Administration (FDA).
This critical certification marks an important step forward in the dental field in improving patient comfort and optimizing surgical procedures.
DentalJect™ is the world’s first precision jet system designed specifically for oral local anesthesia. It uses low-temperature, drug-free fine mist spray technology to painlessly anesthetize oral mucosal areas such as the palate, gums and inner cheeks in just two seconds.
This system effectively replaces traditional local anesthetic gels, eliminating its cumbersome operation and waiting time, allowing clinicians to perform anesthesia injection operations immediately.
“One of the responsibilities of a dentist is to alleviate the fear of pain in their patients,” said Dr. Jacob Liebovici, a practicing dentist and inventor of the DentalJect system.
DentalJect was created to solve this long-standing problem. This technology will become the new industry standard, allowing us to quickly and accurately anesthetize the most sensitive areas of the mouth, bringing unprecedented improvements to patients and dental practices.”
DentalJect can achieve an immediate anesthesia effect, greatly alleviating patients’ pain, fear and anxiety when receiving dental injections.
At the same time, the device is designed to be operated with one hand, which is easy to integrate into the dentist’s existing clinical process, thereby improving overall treatment efficiency.
It significantly improves patient satisfaction by reducing the time of the visit and the cancellation rate caused by anxiety.
Ethan Mandelup, CEO of VCS Medical, added: “The FDA 510(k) clearance means that our technology has passed rigorous testing and data verification to prove its safety and effectiveness.
DentalJect provides a fast, drug-free, and comfortable injection experience that redefines the dental anesthesia process.
We are committed to bringing a more empathetic way of care to every patient, eliminating their fear of injections, and shaping a gentler future for the dental industry.”
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