VCS Medical has announced that its flagship dental product, DentalJect™, has received 510(k) clearance from the US Food and Drug Administration (FDA), according to a June 17, 2025, press release. The company believes that this milestone marks a major advancement in patient comfort and procedural efficiency for dental professionals in the United States.
DentalJect™, a first-of-its-kind topical anesthetic delivery system designed specifically for the oral cavity, uses a precisely delivered burst of drug-free cryogenic spray to painlessly numb targeted areas of the oral mucosa, including the palate, gingiva, and inner cheeks, in less than 2 seconds. DentalJect™ eliminates the wait time and mess associated with traditional topical numbing gels, enabling clinicians to immediately proceed with injections.
“Dentists have an important responsibility in addressing patient fears and aversion to pain,” says Dr. Jacob Liebovici, licensed dentist and founder of the DentalJect system. “This device was created to address these issues, which are long overdue. DentalJect will be the new standard. With DentalJect, we’re able to numb even the most sensitive areas quickly, predictably, and without compromise. It will be transformative for patients and dental practices nationwide.”
DentalJect produces an immediate numbing effect that helps reduce not only the pain of dental injections but also the fear and anxiety that patient’s commonly experience when receiving them. Its intuitive, single-handed operation allows it to be easily integrated into clinicians’ current workflows, enabling them to enhance patient satisfaction while shortening chair time and minimizing the incidence of cancellations related to anxiety.
“Receiving FDA 510(k) clearance affirms we have successfully demonstrated the safety and effectiveness of our technology through rigorous testing and comprehensive data,” says Ethan Mandelup, CEO of VCS Medical. “Our technology delivers fast, drug-free comfort that redefines the injection experience. For us, a compassionate practice is one that removes fear from the equation. We’re proud to be building the future of comfortable dental care for everyone.”
