Aniti-Snore Mouthguard+— 510(k) K231138

Substantially Equivalent

Oscimed SA

FDA 510(k) clearance K231138 for Aniti-Snore Mouthguard+, Substantially Equivalent on 2024-01-16. Applicant: Oscimed SA.

Clearance details

Applicant: Oscimed SA
Product code: Code LRK
Advisory panel: Dental
Date received: 2023-04-21
Decision date: 2024-01-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Suisse, CH

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.