Dormiva Anti-Snoring Mouth Guard— 510(k) K261134
Substantially EquivalentKoncept Innovators, Inc.
FDA 510(k) clearance K261134 for Dormiva Anti-Snoring Mouth Guard, Substantially Equivalent on 2026-05-14. Applicant: Koncept Innovators, Inc.. Device class: 2.
Summary
Koncept Innovators' Dormiva Anti-Snoring Mouth Guard is filed under LRK, anti-snoring devices.
Class II, 21 CFR 872.5570. Dental is both the classification panel and the review panel. It came in as a Special 510(k).
Koncept Innovators filed from Myrtle Beach, South Carolina. The decision came 37 calendar days after receipt (April 7 to May 14, 2026).
Clearance details
- Applicant
- Koncept Innovators, Inc.
- Product code
- Product code LRK
- Device class
- Class 2
- Regulation
- 21 CFR 872.5570
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Myrtle Beach, SC, US
Recent devices under product code LRK
view allAdverse events under product code LRK
product code LRK- Injury
- 246
- Malfunction
- 1,044
- Total
- 1,290
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.