2014 InterActive/SwishActive System— 510(k) K143011

Substantially Equivalent

Implant Direct Sybron Manufacturing, LLC

FDA 510(k) clearance K143011 for 2014 InterActive/SwishActive System, Substantially Equivalent on 2015-07-16. Applicant: Implant Direct Sybron Manufacturing, LLC.

Clearance details

Applicant: Implant Direct Sybron Manufacturing, LLC
Product code: Code DZE
Advisory panel: Dental
Date received: 2014-10-20
Decision date: 2015-07-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Thousand Oaks, CA, 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.