You are here
Zyppah® Anti-Snoring Device Awarded First "Dual Action" Over-The-Counter 510k Clearance from the Food & Drug Administration
RENO, Nev., March 18, 2019 /PRNewswire/ -- Zyppah announces that after six years on the market, it has become the #1 marketed anti-snoring device and has been granted the necessary clearances by the FDA to be made available OTC (over-the-counter). As of January 21, 2019, Zyppah and its creator, Dr. Jonathan Greenburg, DDS, were awarded with FDA registration #K182312. Zyppah's certification included a "first" ranking when compared against the category monograph to feature a wholly unique, dual-action feature that advances the mandible while repositioning the tongue to keep it from blocking the airway; the reason snoring occurs. Zyppah® retails for $99.95 and is available on Zyppah.com and Amazon.com.
"This is a major breakthrough," said the creator and CEO of Zyppah®, Dr. Jonathan Greenburg, DDS. "Zyppah has been the leading snoring appliance for the past three years."
As noted in the certification from the FDA: "the Zyppah® Anti-Snoring Appliance is intended for use by adults (18 years or older) as an aid to reduce snoring. Biocompatibility testing results demonstrated that Zyppah is biocompatible under ISO 10993, including cytotoxicity, sensitization, and irritation testing. The device was shown to meet the requirements of the ISO 10993 guidelines for each of these tests. All materials used in the device are certified USP Class VI and used in many other currently marketed medical devices."
About: Zyppah, Inc. (Happy Z's spelled backwards) is an A+ rated Better Business Bureau company, created by the preeminent U.S. expert on snoring and sleep apnea, Dr. Jonathan Greenburg, DDS. Zyppah® is a patented, clinically proven and FDA-certified mouthpiece featuring both a mandible advancer and a "seat belt for the tongue" to keep it from blocking the airway. NBA Hall of Famer and notorious former snorer, Shaquille O'Neal, serves as a global ambassador for the product. Zyppah® is the consumer-packaged goods arm of a family of companies which address these issues. Five Snore Expert Centers in California provide customized diagnosis and treatments. Sleep Certified is a national referral program that connects consumers with dentists who are trained specifically for snoring and sleep apnea treatment through Sleep Certified's continuing education program. Zyppah, Inc. is headquartered in Reno, Nevada.
Alyson Dutch / Macy Harrell
BROWN + DUTCH PR, INC.
View original content to download multimedia:http://www.prnewswire.com/news-releases/zyppah-anti-snoring-device-awarded-first-dual-action-over-the-counter-510k-clearance-from-the-food--drug-administration-300813600.html