510(k) K984483— A-SOFT RELINER

Substantially Equivalent

S & C Polymer GmbH

Clearance details

Applicant: S & C Polymer GmbH
Product code: Code EBI
Advisory panel: Dental
Date received: 1998-12-16
Decision date: 1999-02-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elmshorn, DE

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.