POLYCLEAN— 510(k) K921564

Substantially Equivalent

Medical Polymers, Inc.

FDA 510(k) clearance K921564 for POLYCLEAN, Substantially Equivalent on 1992-08-10. Applicant: Medical Polymers, Inc..

Clearance details

Applicant: Medical Polymers, Inc.
Product code: Code EFB
Advisory panel: Dental
Date received: 1992-04-01
Decision date: 1992-08-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code EFB

product code EFB

Injury: 133
Malfunction: 562
Total: 695

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.