Dormiva Anti-Snoring Mouth Guard— 510(k) K261134

Substantially Equivalent

Koncept Innovators, Inc.

FDA 510(k) clearance K261134 for Dormiva Anti-Snoring Mouth Guard, Substantially Equivalent on 2026-05-14. Applicant: Koncept Innovators, Inc..

Clearance details

Applicant: Koncept Innovators, Inc.
Product code: Code LRK
Advisory panel: Dental
Date received: 2026-04-07
Decision date: 2026-05-14
Decision: Substantially Equivalent
Clearance type: Special
Location: Myrtle Beach, SC, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LRK

product code LRK

Injury: 246
Malfunction: 1,044
Total: 1,290

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.