EndSnor
by Dockstader Orthodontic Lab, Inc. 510(k)
Active
510(k) K072731
Overview
The EndSnor is a dental device classified as an Anti-Snoring Device, designed to reduce snoring by maintaining an open airway during sleep. It functions as a removable oral appliance that fits over the teeth, helping to position the jaw and tongue to prevent airway obstruction.
This device is intended for single-use or reusable application in a dental setting, depending on the patient’s needs and the orthodontic professional’s recommendation. Supplied in sterile packaging, it is regulated under FDA 510(k) clearance (K072731) and falls under the classification of Class II medical devices. Multiple sizes are available to accommodate different patient anatomies, ensuring a customizable fit.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK072731 | Date12 Jun 2008 | 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- Withdrawn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
- 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
How is the EndSnor device intended to be used in a clinical setting and what determines whether it is single-use or reusable?
The EndSnor is a removable oral appliance designed to reduce snoring by maintaining an open airway during sleep. It achieves this by positioning the jaw and tongue to prevent airway obstruction. Whether it is used as a single-use or reusable device depends on the patient’s specific needs and the recommendation of the orthodontic professional overseeing treatment. The device is supplied in sterile packaging, ensuring readiness for clinical use.
What sizes are available for the EndSnor, and how does this accommodate different patients?
The EndSnor comes in multiple sizes to accommodate varying patient anatomies. This customizable fit ensures that the device can be tailored to individual needs, improving comfort and effectiveness in maintaining an open airway during sleep. The manufacturer provides detailed sizing guidance to help clinicians select the appropriate size for each patient.
Is the EndSnor device sterile when it arrives, and how should it be stored?
Yes, the EndSnor is supplied in sterile packaging, ensuring it is ready for immediate use in a clinical setting. To maintain sterility and functionality, it should be stored in a clean, dry environment, protected from direct sunlight and extreme temperatures. Follow the manufacturer’s storage instructions to preserve the device’s integrity until use.
What regulatory pathway does the EndSnor follow, and what does this mean for clinicians?
The EndSnor is regulated under the FDA’s 510(k) clearance process, specifically classified as a Class II medical device under the product code LRK. This means it has been determined to be substantially equivalent to a legally marketed device and meets FDA requirements for safety and effectiveness. Clinicians can rely on this regulatory clearance as part of their decision-making process when considering the device for patient use.