SLEEPAPP— 510(k) K182202

Substantially Equivalent

Comfort Acrylics, Inc.

FDA 510(k) clearance K182202 for SLEEPAPP, Substantially Equivalent on 2019-01-11. Applicant: Comfort Acrylics, Inc..

Clearance details

Applicant: Comfort Acrylics, Inc.
Product code: Code LRK
Advisory panel: Dental
Date received: 2018-08-14
Decision date: 2019-01-11
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Camas, WA, US

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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.