AIRWAYEASE MAS— 510(k) K090436

Substantially Equivalent

Orthoplant Dental Lab

FDA 510(k) clearance K090436 for AIRWAYEASE MAS, Substantially Equivalent on 2010-04-16. Applicant: Orthoplant Dental Lab.

Clearance details

Applicant: Orthoplant Dental Lab
Product code: Code LRK
Advisory panel: Dental
Date received: 2009-02-19
Decision date: 2010-04-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bella Vista, New South Wales, AU

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.