ASA ORAL APPLIANCES— 510(k) K130504

Substantially Equivalent

American Sleep Association

FDA 510(k) clearance K130504 for ASA ORAL APPLIANCES, Substantially Equivalent on 2013-10-18. Applicant: American Sleep Association.

Clearance details

Applicant: American Sleep Association
Product code: Code LRK
Advisory panel: Dental
Date received: 2013-02-27
Decision date: 2013-10-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chesterland, OH, 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.