MAJOR.BASE 20— 510(k) K081884

Name: FDA 510(k) clearance K081884
Creator: U.S. Food and Drug Administration
Published: 2008-10-08

Substantially Equivalent

Major Prodotti Dentari S.P.A.

FDA 510(k) clearance K081884 for MAJOR.BASE 20, Substantially Equivalent on 2008-10-08. Applicant: Major Prodotti Dentari S.P.A.. Device class: 2.

Clearance details

Applicant: Major Prodotti Dentari S.P.A.
Product code: Code EBI
Device class: Class 2
Regulation: 21 CFR 872.3760
Advisory panel: Dental
Date received: 2008-07-02
Decision date: 2008-10-08
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Monacalieri (Torino), IT

Download summary PDF View on FDA.gov ↗

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K082700 — TEMPORARY COLD.V AND SELF-CURE DENTINE2008-12-09
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Adverse events under product code EBI

product code EBI

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.