Buzzy by Pain Care Labs Receives FDA Clearance, Reducing Pain and Anxiety in Dental Injections

The United States Food and Drug Administration (FDA) has recently granted 510(k) clearance to a medical device called Buzzy developed by Pain Care Labs. Buzzy employs innovative technology to minimize pain during local anesthesia injections, and is designed for individuals who experience anxiety related to dental visits.

Mechanical Stimulation and Ice Application 

Buzzy utilizes a combination of mechanical stimulation (M-Stim®) and ice application to mitigate the discomfort associated with dental injections. When placed on the bones above or below the mouth, the vibrating ice unit has reportedly been proven to be more effective in reducing injection pain compared to traditional methods like topical gels, sprays, intraoral devices, or the conventional “jiggling the cheek” technique.

Dr Amy Baxter, CEO of Pain Care Labs, and the creator of Buzzy, emphasizes the significance of this development for oral healthcare. She remarks, “The relationship between oral health and good overall health is well-established. Not only can Buzzy be used to reduce the barrier to regular dental care, but vibration and cold can be used after oral surgery to reduce pain instead of opioids.”

Importance of Regular Dental Visits

Regular dental visits play a crucial role in maintaining oral health, akin to an annual physical exam for general well-being. However, dental anxiety and needle fear often deter people from seeking necessary dental treatments. THerefore, Buzzy has the potential to revolutionize dental care by enabling a more comfortable and pleasant experience for patients.

The device’s unique combination of M-Stim and ice offers a pain relief strategy for both during and after dental procedures. According to a press release, M-Stim optimizes gate control pain relief by utilizing specific frequencies, while the calculated cold energy prompts the brain to filter out pain signals. The compact, palm-sized design of Buzzy allows easy placement near treatment areas, ensuring an efficient and streamlined procedure while enhancing the patient’s comfort.

Testimonials from Dental Professionals

Endodontists and dental practitioners have already hailed the benefits of Buzzy in their practices, says the manufacturer. Dr Rajiv G. Patel of Endodontic Excellence in Flower Mound, Texas, remarks, “As an endodontist, I see many patients who are anxious about injections. I have used Buzzy for years, and patients really like the experience. The injections go smoothly, and our team saves time.”

Buzzy has reportedly aided in blocking pain in over 45 million needle procedures, including dental injections. Backed by more than 80 studies, the device is said to have demonstrated consistent results in reducing needle pain, fear, and anxiety, even mitigating the fainting response.

Dr Baxter expresses her excitement about this milestone achievement, stating, “The new FDA 510K clearance for dental procedures marks a pivotal moment in our mission to eliminate needless pain, reduce opioid use, and overcome fear in medical settings. We are thrilled to officially expand the application of our pain reduction technology to the dental field, providing patients with a relaxed, pleasant experience during their dental visits.”

With Buzzy’s pain reduction technology now available for dental use, the company expects that it will positively impact oral healthcare practices worldwide, making dental visits more accessible and less intimidating for individuals of all ages.

Click here for more information on Buzzy by Pain Care Labs.