510(k) K262300— Denture Base Resin V2

Substantially Equivalent

Formlabs Ohio, Inc.

Clearance details

Applicant
Formlabs Ohio, Inc.
Product code
Code EBI
Advisory panel
Dental
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Abbreviated
Location
Millbury, OH, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code EBI

product code EBI
Other
1
Total
1

Source: openFDA MAUDE database, through . 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.