IMPLANTIUM ABUTMENTS— 510(k) K052823

Name: FDA 510(k) clearance K052823
Creator: U.S. Food and Drug Administration
Published: 2006-02-21

Substantially Equivalent

Dentium, Inc.

FDA 510(k) clearance K052823 for IMPLANTIUM ABUTMENTS, Substantially Equivalent on 2006-02-21. Applicant: Dentium, Inc.. Device class: 2.

Clearance details

Applicant: Dentium, Inc.
Product code: Code NHA
Device class: Class 2
Regulation: 21 CFR 872.3630
Advisory panel: Dental
Date received: 2005-10-04
Decision date: 2006-02-21
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Laguna Niguel, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code NHA

product code NHA

Injury: 1,270
Malfunction: 2,860
Total: 4,130

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.