FLEXO DENTAL RESIN MATERIAL— 510(k) K061501

Substantially Equivalent

Aci, Inc.

FDA 510(k) clearance K061501 for FLEXO DENTAL RESIN MATERIAL, Substantially Equivalent on 2006-07-26. Applicant: Aci, Inc..

Clearance details

Applicant: Aci, Inc.
Product code: Code EBI
Advisory panel: Dental
Date received: 2006-05-31
Decision date: 2006-07-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mission, KS, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code EBI

product code EBI

Other: 1
Total: 1

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.