MIS CREST WIDENER— 510(k) K080458

Substantially Equivalent

Mis - Implant Technologies , Ltd.

FDA 510(k) clearance K080458 for MIS CREST WIDENER, Substantially Equivalent on 2008-12-17. Applicant: Mis - Implant Technologies , Ltd..

Clearance details

Applicant: Mis - Implant Technologies , Ltd.
Product code: Code MQN
Advisory panel: Dental
Date received: 2008-02-20
Decision date: 2008-12-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shlomi, IL

Download summary PDF View on FDA.gov ↗

Adverse events under product code MQN

product code MQN

Injury: 346
Total: 346

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.