Dental Implant OKTAGON Bone Level— 510(k) K143539

Name: FDA 510(k) clearance K143539
Creator: U.S. Food and Drug Administration
Published: 2015-08-31

Substantially Equivalent

Hager& Meisinger GmbH

FDA 510(k) clearance K143539 for Dental Implant OKTAGON Bone Level, Substantially Equivalent on 2015-08-31. Applicant: Hager& Meisinger GmbH. Device class: 2.

Clearance details

Applicant: Hager& Meisinger GmbH
Product code: Code DZE
Device class: Class 2
Regulation: 21 CFR 872.3640
Advisory panel: Dental
Date received: 2014-12-15
Decision date: 2015-08-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Neuss, DE

Download summary PDF View on FDA.gov ↗

Recent devices under product code DZE

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K260463 — ZEROS Dental Implant System2026-08-19
K251188 — UNIQA® Dental Implants System2026-06-25
K250806 — Dental Implant System2026-06-18
K251232 — MegaGen Zygoma Dental Implant System2026-06-18
K260006 — INOSS System2026-06-17

More clearances from Hager& Meisinger GmbH

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K250123 — Master-Pin X (MP Pin with thread) (36BMP000030 / MP30)2025-09-29
K240321 — MP Pin flat without thread (36BMP000020/MP20)2024-10-17
K201210 — The Micro Screw System, Micro Screw System Basic2021-10-08
K173819 — MyPlant II Implant System2018-08-09
K180360 — OKTAGON Implant System2018-05-10

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.