LUNA DENTAL IMPLANT SYSTEM— 510(k) K123155

Name: FDA 510(k) clearance K123155
Creator: U.S. Food and Drug Administration
Published: 2013-10-31

Substantially Equivalent

Shinhung Mst Co., Ltd.

FDA 510(k) clearance K123155 for LUNA DENTAL IMPLANT SYSTEM, Substantially Equivalent on 2013-10-31. 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: 2012-10-09
Decision date: 2013-10-31
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Wonju-Si, KR

Download summary PDF View on FDA.gov ↗

Recent devices under product code DZE

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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
K162867 — MagDen Dental Implant System2017-07-26

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.