ZQUIET MOUTHPIECE— 510(k) K090503

Substantially Equivalent

Sleeping Well, LLC

FDA 510(k) clearance K090503 for ZQUIET MOUTHPIECE, Substantially Equivalent on 2009-03-10. Applicant: Sleeping Well, LLC.

Clearance details

Applicant: Sleeping Well, LLC
Product code: Code LRK
Advisory panel: Dental
Date received: 2009-02-25
Decision date: 2009-03-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Crofton, MD, 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.