Panthera Dental Milled Bars— 510(k) K173466

Substantially Equivalent

Panthera Dental, Inc.

FDA 510(k) clearance K173466 for Panthera Dental Milled Bars, Substantially Equivalent on 2018-01-26. Applicant: Panthera Dental, Inc..

Clearance details

Applicant
Panthera Dental, Inc.
Product code
Code NHA
Advisory panel
Dental
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Quebec City, CA
Download summary PDFView on FDA.gov ↗

Adverse events under product code NHA

product code NHA
Injury
1,270
Malfunction
2,860
Total
4,130

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.