PANA SPRAY Plus— 510(k) K163483

Substantially Equivalent

Nakanishi, Inc.

FDA 510(k) clearance K163483 for PANA SPRAY Plus, Substantially Equivalent on 2017-08-15. Applicant: Nakanishi, Inc..

Clearance details

Applicant: Nakanishi, Inc.
Product code: Code EFB
Advisory panel: Dental
Date received: 2016-12-12
Decision date: 2017-08-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kanuma-Shi, JP

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.