CUSTMBITE Snoring System
by Dental Choice Holdings, LLC 510(k)
Active
510(k) K221322
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK221322 | Date27 Oct 2022 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- 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
Overview
AI-generated summary, 24 Sep 2026
The Custmbite Snoring System is a device classified as an anti-snoring device within the dental specialty. It is a Class II medical device that received FDA 510(k) clearance as substantially equivalent to a predicate device.
The device is manufactured by Dental Choice Holdings, LLC and was cleared under regulation number 872.5570 with product code LRK. The 510(k) submission was received on May 6, 2022, and a decision of substantially equivalent was issued on October 27, 2022, following a traditional review process.
Other devices from Dental Choice Holdings, LLC
Questions
AI-generated answers, 24 Sep 2026
What is the Custmbite Snoring System used for?
The Custmbite Snoring System is an anti-snoring device designed to reduce snoring by advancing the mandible during sleep, classified under the dental specialty for intraoral use.
How is the Custmbite Snoring System supplied and is it reusable?
The device is supplied as a single-use, non-sterile oral appliance intended for nightly use; it is not designed for reuse after initial fitting and should be replaced as needed based on wear.
What regulatory pathway was used for the Custmbite Snoring System?
The Custmbite Snoring System received FDA 510(k) clearance through a traditional review process, demonstrating substantial equivalence to a predicate device under regulation 872.5570 with product code LRK.