AFTAMED MOUTHWASH; AFTAMED GEL; AFTAMED SPRAY; AFTAMED SHIELD; AFTAMED JUNIOR GEL— 510(k) K130959

Substantially Equivalent

Bioplax Limited

FDA 510(k) clearance K130959 for AFTAMED MOUTHWASH; AFTAMED GEL; AFTAMED SPRAY; AFTAMED SHIELD; AFTAMED JUNIOR GEL, Substantially Equivalent on 2014-04-04. Applicant: Bioplax Limited.

Clearance details

Applicant: Bioplax Limited
Product code: Code OLR
Advisory panel: Unknown
Date received: 2013-04-05
Decision date: 2014-04-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bellingham, WA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code OLR

product code OLR

Death: 3
Total: 3

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.