SILICONT BUR BLOCK— 510(k) K921406

Name: FDA 510(k) clearance K921406
Creator: U.S. Food and Drug Administration
Published: 1992-04-28

Substantially Equivalent

Innovators, Inc.

FDA 510(k) clearance K921406 for SILICONT BUR BLOCK, Substantially Equivalent on 1992-04-28. Applicant: Innovators, Inc.. Device class: 1.

Clearance details

Applicant: Innovators, Inc.
Product code: Code EJL
Device class: Class 1
Regulation: 21 CFR 872.3240
Advisory panel: Dental
Date received: 1992-03-20
Decision date: 1992-04-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jefferson City, MO, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code EJL

product code EJL

Other: 1
Total: 1

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.