HARD RELINER— 510(k) K011277

Substantially Equivalent

S & C Polymer GmbH

FDA 510(k) clearance K011277 for HARD RELINER, Substantially Equivalent on 2001-06-26. Applicant: S & C Polymer GmbH.

Clearance details

Applicant: S & C Polymer GmbH
Product code: Code EBI
Advisory panel: Dental
Date received: 2001-04-26
Decision date: 2001-06-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elmshorn, DE

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.