Dental Injection Pain Now Under Control - Buzzy® Receives New FDA 510K Indication

The COVID-19 pandemic increased dental anxiety among the most fearful patients. Proven Buzzy device is now FDA-indicated to control dental injection pain.

ATLANTA, GEORGIA, U.S., July 19, 2023/EINPresswire.com/ -- Regular dental visits are as important as getting an annual physical exam. Yet many of us avoid the dentist because of anxiety and needle fear. This worsened during the COVID-19 pandemic.

“As an endodontist, I see many patients who are anxious about injections,” noted Dr. Rajiv G. Patel of Endodontic Excellence, Flower Mound, Texas. “I have used Buzzy for years and patients really like the experience. The injections go smoothly and our team saves time."

Dentists can now deliver local anesthesia injections with less pain, fear, and anxiety, thanks to 510(k) clearance from the United States Food and Drug Administration (FDA) for a medical device called Buzzy. When the vibrating ice unit is placed on the bones above or below the mouth, research shows the pain of injection is reduced more than topical gels, sprays, intraoral devices, or the “jiggling the cheek” technique.

“The relationship between oral health and good overall health is well-established,” observes Dr. Amy Baxter, CEO of Pain Care Labs, creator of Buzzy. “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.”

Buzzy's clearance holds immense potential to improve oral healthcare for millions worldwide. The unique combination of mechanical stimulation (M-Stim^®) and ice provides relief during or after dental procedures. M-Stim's frequency optimizes gate control pain relief, while the calculated cold energy causes the brain to filter out pain. The palm-sized device is easily placed near treatment areas, improving the patient experience while maintaining the efficiency of the procedure.

Buzzy has blocked pain from over 45 million needle procedures, including dental injections. Over 80 studies show that Buzzy reduces needle pain, fear, and anxiety - and even reduces the fainting response.

"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," observed Dr. Baxter. "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. Buzzy could transform the way people think about the dentist."

ABOUT PAIN CARE LABS

Pain Care Labs is the industry leader in non-invasive pain relief solutions. Established in 2006 by emergency physician and pain researcher Amy Baxter MD, the Company is dedicated to effective, reusable, drug-free pain solutions. Dr. Baxter speaks on public health topics including vaccine refusal (TEDMED) and the impact of needle fear on COVID vaccination (HHS). Most recently, she spoke at TED2023 about options instead of opioids after surgery. FDA-cleared Buzzy^®, the flagship product, has been used to block the pain from over 45 million needle procedures. FDA-cleared VibraCool^® relieves musculoskeletal pain from injury and overuse. The Company's award-winning solutions are supported by over 80 independent clinical trials. The patented M-Stim^® neuromodulation platform gives power over pain.

ADDITIONAL LINKS

https://www.sciencedirect.com/science/article/pii/S0020653922001496
https://www.guardianlife.com/oral-and-overall-health
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4900413/
https://my.clevelandclinic.org/health/diseases/22594-dentophobia-fear-of-dentists#:~:text=How%20common%20are%20dentophobia%20and,in%20females%20than%20in%20males.

SOCIAL TAGS

#BugsNotDrugs
#PowerOverPain
#OptionsNotOpioids
#WhatWorksForPain

Jennifer Tipping
Buzzy®, VibraCool®, DistrACTION® - MMJ Labs, LLC d/b/a Pain
+1 877-805-2899
jtipping@paincarelabs.com
Visit us on social media:
Facebook
Twitter
LinkedIn
Instagram
YouTube
TikTok