REVOIS IMPLANT SYSTEM— 510(k) K113042

Substantially Equivalent

Riemser Arzneimittel AG

FDA 510(k) clearance K113042 for REVOIS IMPLANT SYSTEM, Substantially Equivalent on 2013-03-08. Applicant: Riemser Arzneimittel AG.

Clearance details

Applicant: Riemser Arzneimittel AG
Product code: Code DZE
Advisory panel: Dental
Date received: 2011-10-12
Decision date: 2013-03-08
Decision: Substantially Equivalent
Clearance type: Special
Location: Durham, NC, US

Download summary PDF View 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, 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.