DentalJect

The DentalJect™ is a prescription vapocoolant device that attaches to a standard dental syringe and dispenses a non-medicated, non-flammable refrigerant spray to the oral cavity. It is used to numb intact mucous membrane in the mouth before injections by creating a minimally-sized cooling area that produces a temporary anesthetic effect.

The device uses HFO 1234 Ze (95%) with ethanol and natural spearmint flavoring, differs from the predicate Chillit which used HFC-134a, and includes a dental connector attachment allowing compatibility with standard dental syringes (11-13mm barrel diameter). It provides faster application time (1-2 seconds on oral mucosa) compared to some reference devices (4-10 seconds), and is designed specifically for oral cavity use rather than skin.

ISO 10993-1 biocompatibility evaluation including cytotoxicity (ISO 10993-5:2009), sensitization (ISO 10993-10:2021), irritation (ISO 10993-23:2021), acute systemic toxicity (ISO 10993-11:2017), pyrogenicity (USP-NF <151>), and CFR Part 16 §1500.45 flammability testing. End-user usability validation followed FDA guidance on Human Factors and Usability Engineering.

The device is substantially equivalent because it delivers thermal energy via the same vapocoolant spray mechanism as the predicate Chillit for topical anesthesia on intact mucous membrane, despite using a lower-GWP refrigerant formulation and being specifically configured for dental syringe attachment. Non-clinical bench testing including needle clearance, fit/form compatibility, flammability, temperature profile, and comprehensive biocompatibility testing demonstrate that differences in design, formulation, and delivery method do not affect the fundamental intended use of providing topical anesthesia before injections.