Chrysalis Intelligence · Sponsors · Megagen Implant Co., Ltd.

Megagen Implant Co., Ltd.

Daegu, KR · 19 510(k) clearances

Total clearances
19
2020-02-13 → 2026-06-18
Last 12 months
1
Product codes
5
Most recent
2026-06-18
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
DZE Implant, Endosseous, Root-Form Class II Dental 8 2026-06-18
NHA Abutment, Implant, Dental, Endosseous Class II Dental 7 2025-01-13
EIA 2 2024-03-21
LLZ System, Image Processing, Radiological Class II Radiology 1 2023-10-20
OAS X-Ray, Tomography, Computed, Dental Class II Radiology 1 2022-12-06
Filings

All 510(k) clearances (19)

Date K-number Device Code Class Specialty
2026-06-18 K251232 MegaGen Zygoma Dental Implant System DZE Class II Dental
2025-01-13 K242030 MegaGen Dental Implant Abutment NHA Class II Dental
2024-12-27 K241972 BLUEDIAMOND IMPLANT DZE Class II Dental
2024-09-18 K234142 TiGEN Abutment, PMMA Abutment and Scan Healing Abutment NHA Class II Dental
2024-03-21 K240754 N2 EIA
2024-01-22 K233450 MegaGen Dental Implant Abutment - Scan Healing Abutment; Temporary Abutment; Temporary Cylinder; Comfort Cap; Healing Cap; Healing Cap Screw; Milling Abutment; EZ Post Abutment; Extra EZ Post Abutment; EZ Post Cylinder; ZrGEN Abutment; Multi-unit Abutment; Multi-unit Angled Abutment; AXA Abutment (Straight); AXA Abutment (Angled); Abutment Screw; Cylinder Screw; Crown Screw NHA Class II Dental
2023-12-07 K231967 ARi ExCon Implant System DZE Class II Dental
2023-10-20 K223909 R2GATE Lite TM LLZ Class II Radiology
2023-10-11 K230618 MegaGen Dental Implant Systems Portfolio - MR Conditional DZE Class II Dental
2023-07-18 K223339 Bone Chamber Implant DZE Class II Dental
2023-04-05 K211556 N2 EIA
2023-01-06 K211812 BLUEDIAMOND IMPLANT, Abutment Screw DZE Class II Dental
2022-12-06 K222219 R2 Studio Q/RCT820 OAS Class II Radiology
2022-11-10 K220562 TiGEN Abutment, ZrGEN Abutment and Scan Healing Abutment NHA Class II Dental
2022-02-03 K210826 Healing Abutment, Cover Screw NHA Class II Dental
2021-10-20 K203808 Multi-unit Abutment, Multi-unit Angled Abutment NHA Class II Dental
2021-08-28 K203554 AnyOne External Implant System DZE Class II Dental
2021-06-22 K210161 AnyOne Onestage Implant System DZE Class II Dental
2020-02-13 K192614 Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet Abutment NHA Class II Dental