OSSEOINTEGRATED FIXTURES-TISSUE INTEGR— 510(k) K841551

Name: FDA 510(k) clearance K841551
Creator: U.S. Food and Drug Administration
Published: 1984-06-22

Substantially Equivalent

Bofors Nobelpharma, Inc.

FDA 510(k) clearance K841551 for OSSEOINTEGRATED FIXTURES-TISSUE INTEGR, Substantially Equivalent on 1984-06-22. Applicant: Bofors Nobelpharma, Inc.. Device class: 2.

Clearance details

Applicant: Bofors Nobelpharma, Inc.
Product code: Code DZE
Device class: Class 2
Regulation: 21 CFR 872.3640
Advisory panel: Dental
Date received: 1984-04-16
Decision date: 1984-06-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K250806 — Dental Implant System2026-06-18
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K260006 — INOSS System2026-06-17

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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.