J TAC MODEL JT-MD-035, JT-MD-040, JT-MD-045, JT-CL-030— 510(k) K101902

Name: FDA 510(k) clearance K101902
Creator: U.S. Food and Drug Administration
Published: 2011-02-08

Substantially Equivalent

Jeil Medical Corporation

FDA 510(k) clearance K101902 for J TAC MODEL JT-MD-035, JT-MD-040, JT-MD-045, JT-CL-030, Substantially Equivalent on 2011-02-08. Applicant: Jeil Medical Corporation. Device class: 2.

Clearance details

Applicant: Jeil Medical Corporation
Product code: Code DZL
Device class: Class 2
Regulation: 21 CFR 872.4880
Advisory panel: Dental
Date received: 2010-07-08
Decision date: 2011-02-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marietta, GA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code DZL

product code DZL

Injury: 168
Total: 168

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.