MagDen Dental Implant System— 510(k) K162867

Name: FDA 510(k) clearance K162867
Creator: U.S. Food and Drug Administration
Published: 2017-07-26

Substantially Equivalent

Shinhung Mst Co., Ltd.

FDA 510(k) clearance K162867 for MagDen Dental Implant System, Substantially Equivalent on 2017-07-26. Applicant: Shinhung Mst Co., Ltd.. Device class: 2.

Clearance details

Applicant: Shinhung Mst Co., Ltd.
Product code: Code DZE
Device class: Class 2
Regulation: 21 CFR 872.3640
Advisory panel: Dental
Date received: 2016-10-13
Decision date: 2017-07-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wonju-Si, KR

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 Shinhung Mst Co., Ltd.

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K221752 — Stella2023-06-04
K223395 — Luna Dental Implant System2023-02-03
K221317 — S-Mono2023-01-13
K200189 — Luna Dental Implant System- Healing Abutment2020-02-26
K160106 — LUNA DENTAL IMPLANT SYSTEM2016-08-26

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.