PANA SPRAY PLUS— 510(k) K131014

Substantially Equivalent

Nsk America Corp.

FDA 510(k) clearance K131014 for PANA SPRAY PLUS, Substantially Equivalent on 2013-08-12. Applicant: Nsk America Corp..

Clearance details

Applicant: Nsk America Corp.
Product code: Code EFB
Advisory panel: Dental
Date received: 2013-04-11
Decision date: 2013-08-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Richardson, 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.