CLEARSPLINT ES— 510(k) K111828

Substantially Equivalent

Astron Dental Corporation

FDA 510(k) clearance K111828 for CLEARSPLINT ES, Substantially Equivalent on 2011-10-26. Applicant: Astron Dental Corporation.

Clearance details

Applicant: Astron Dental Corporation
Product code: Code MQC
Advisory panel: Unknown
Date received: 2011-06-28
Decision date: 2011-10-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lake Zurich, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MQC

product code MQC

Injury: 377
Total: 377

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.