Breathe EZ Anti-Snoring Device
by D&S Redhage 510(k)
Active
510(k) K022891
Overview
The Breathe EZ Anti-Snoring Device is an intraoral anti-snoring and anti-bruxing device. It consists of an oval plate positioned between the upper and lower teeth and gums, featuring an integrated port (tube) to facilitate mouth breathing and prevent tongue or lip obstruction. The device is intended to reduce or alleviate snoring and to prevent bruxing, clenching, and grinding of the teeth while sleeping.
The device is supplied by D&S Redhage and is regulated under product code LRK. It is a Class II medical device authorized through the FDA 510(k) premarket notification process. The device is intended for single-patient use in a home or clinical setting and should be stored in a dry environment. No information on MRI compatibility or sterilization requirements is provided in the available data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK022891 | Date19 Feb 2003 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- Full name
- The Breathe Ez Anti-Snoring Device
- 510(k) Number
- FDA Product Code
- LRK
- Device Class
- Class II
- Regulation
- 21 CFR Part 872.5570
- Advisory Committee
- Dental
- FDA Decision
- SESE Substantially Equivalent
Questions
What is the Breathe EZ device used for?
The Breathe EZ is an intraoral anti-snoring and anti-bruxing device. It is designed to reduce or alleviate snoring while also preventing bruxing, clenching, and grinding of the teeth during sleep. The device fits between the upper and lower teeth and gums.
How does the device facilitate breathing during sleep?
The device includes an integrated port or tube that allows for mouth breathing. This design feature is intended to prevent obstruction of the tongue or lips, which can contribute to snoring and breathing difficulties during sleep.
Is the Breathe EZ device intended for single or multiple patients?
The Breathe EZ is intended for single-patient use. It is designed for use in either a home or clinical setting, but it should not be shared between different individuals due to hygiene and fit considerations.
How should the device be stored?
The device should be stored in a dry environment. Proper storage helps maintain the integrity of the materials and ensures the device remains in optimal condition for use.
What regulatory pathway was used for this device?
The Breathe EZ was authorized through the FDA 510(k) premarket notification process. It is classified as a Class II medical device under product code LRK and was determined to be substantially equivalent to existing devices.