Luna Dental Implant System- Healing Abutment— 510(k) K200189

Name: FDA 510(k) clearance K200189
Creator: U.S. Food and Drug Administration
Published: 2020-02-26

Substantially Equivalent

Shinhung Mst Co., Ltd.

FDA 510(k) clearance K200189 for Luna Dental Implant System- Healing Abutment, Substantially Equivalent on 2020-02-26. Applicant: Shinhung Mst Co., Ltd.. Device class: 2.

Clearance details

Applicant: Shinhung Mst Co., Ltd.
Product code: Code NHA
Device class: Class 2
Regulation: 21 CFR 872.3630
Advisory panel: Dental
Date received: 2020-01-27
Decision date: 2020-02-26
Decision: Substantially Equivalent
Clearance type: Special
Location: Wonju Si, KR

Download summary PDF View on FDA.gov ↗

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More clearances from Shinhung Mst Co., Ltd.

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K221752 — Stella2023-06-04
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K162867 — MagDen Dental Implant System2017-07-26
K160106 — LUNA DENTAL IMPLANT SYSTEM2016-08-26

Adverse events under product code NHA

product code NHA

Injury: 1,270
Malfunction: 2,860
Total: 4,130

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.