SUPERFINE DIAMONDS— 510(k) K771214

Substantially Equivalent

Den-Mat Corp.

FDA 510(k) clearance K771214 for SUPERFINE DIAMONDS, Substantially Equivalent on 1977-07-15. Applicant: Den-Mat Corp..

Clearance details

Applicant: Den-Mat Corp.
Product code: Code EJL
Advisory panel: Dental
Date received: 1977-07-05
Decision date: 1977-07-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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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.