MYO MUNCHEE (OPERATIONS) PTY LTD

Myo Munchee (Operations) Pty Ltd specializes in bite relief pads, which are designed to protect dental work such as braces or crowns from damage caused by teeth grinding or clenching. These devices are intended for use during sleep or when individuals experience heightened teeth pressure, helping to preserve orthodontic appliances and natural teeth.

The company operates from the United States, where it develops and manufactures its bite relief pads. The location aligns with regulatory requirements for medical device production in the region.

Myo Munchee’s bite relief pads are classified as Class I medical devices under US regulations. This classification is typically assigned to low-risk devices, such as dental protection products, which pose minimal risk to patients when used as intended.

Yes, Myo Munchee’s devices are included in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices in the US market, ensuring transparency and traceability for regulatory and clinical purposes.