Acryfree Denture Base Material and Biosens Denture Base Material— 510(k) K150454

Substantially Equivalent

Perflex

FDA 510(k) clearance K150454 for Acryfree Denture Base Material and Biosens Denture Base Material, Substantially Equivalent on 2015-05-26. Applicant: Perflex.

Clearance details

Applicant: Perflex
Product code: Code EBI
Advisory panel: Dental
Date received: 2015-02-20
Decision date: 2015-05-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Netanya, IL

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.