MegaGen Dental Implant Systems Portfolio - MR Conditional— 510(k) K230618

Name: FDA 510(k) clearance K230618
Creator: U.S. Food and Drug Administration
Published: 2023-10-11

Substantially Equivalent

Megagen Implant Co., Ltd.

FDA 510(k) clearance K230618 for MegaGen Dental Implant Systems Portfolio - MR Conditional, Substantially Equivalent on 2023-10-11. Applicant: Megagen Implant Co., Ltd.. Device class: 2.

Clearance details

Applicant: Megagen Implant Co., Ltd.
Product code: Code DZE
Device class: Class 2
Regulation: 21 CFR 872.3640
Advisory panel: Dental
Date received: 2023-03-06
Decision date: 2023-10-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Daegu, 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 Megagen Implant Co., Ltd.

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K242030 — MegaGen Dental Implant Abutment2025-01-13
K241972 — BLUEDIAMOND IMPLANT2024-12-27
K234142 — TiGEN Abutment, PMMA Abutment and Scan Healing Abutment2024-09-18
K240754 — N22024-03-21
K233450 — MegaGen Dental Implant Abutment - Scan Healing Abutment +17 more2024-01-22

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.