Ritter Dental Implant System— 510(k) K160475

Substantially Equivalent

Ritter Implants GmbH & Co. KG

FDA 510(k) clearance K160475 for Ritter Dental Implant System, Substantially Equivalent on 2016-12-14. Applicant: Ritter Implants GmbH & Co. KG.

Clearance details

Applicant
Ritter Implants GmbH & Co. KG
Product code
Code DZE
Advisory panel
Dental
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Biberach, DE
Download summary PDFView on FDA.gov ↗

Adverse events under product code DZE

product code DZE
Death
28
Injury
3,367,041
Malfunction
19,958
Other
13
Total
3,387,040

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.