NOBELDIRECT OD IMPLANT— 510(k) K041876

Name: FDA 510(k) clearance K041876
Creator: U.S. Food and Drug Administration
Published: 2004-08-20

Substantially Equivalent

Nobel Biocare Uas, Inc.

FDA 510(k) clearance K041876 for NOBELDIRECT OD IMPLANT, Substantially Equivalent on 2004-08-20. Applicant: Nobel Biocare Uas, Inc.. Device class: 2.

Clearance details

Applicant: Nobel Biocare Uas, Inc.
Product code: Code DZE
Device class: Class 2
Regulation: 21 CFR 872.3640
Advisory panel: Dental
Date received: 2004-07-12
Decision date: 2004-08-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yorba Linda,, CA, US

Download summary PDF View on FDA.gov ↗

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K041661 — NOBEL BIOCARE ENDOSSEOUS IMPLANTS2004-08-26
K041312 — NOBELRONDO DENTAL CERAMIC-ALUMINA2004-07-23
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Adverse events under product code DZE

product code DZE

Death: 28
Injury: 3,367,041
Malfunction: 19,958
Other: 13
Total: 3,387,040

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.