Pac-Dent Denture Base Resin— 510(k) K210189

Substantially Equivalent

Pac-Dent, Inc.

FDA 510(k) clearance K210189 for Pac-Dent Denture Base Resin, Substantially Equivalent on 2021-07-28. Applicant: Pac-Dent, Inc..

Clearance details

Applicant: Pac-Dent, Inc.
Product code: Code EBI
Advisory panel: Dental
Date received: 2021-01-25
Decision date: 2021-07-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brea, CA, US

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.