Megagen Implant Co., Ltd.
Daegu, KR
Megagen Implant Co., Ltd. appears in FDA device records in Daegu, KR. FDA records list 32 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 32 510(k) clearances for Megagen Implant Co., Ltd. between 2008 and 2026. The busiest year on record is 2023, with 6. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2008 | 1 |
| 2010 | 1 |
| 2012 | 2 |
| 2013 | 3 |
| 2014 | 1 |
| 2015 | 1 |
| 2019 | 4 |
| 2020 | 1 |
| 2021 | 3 |
| 2022 | 3 |
| 2023 | 6 |
| 2024 | 4 |
| 2025 | 1 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K251232 | MegaGen Zygoma Dental Implant System | DZE | Substantially Equivalent | |
| K242030 | MegaGen Dental Implant Abutment | NHA | Substantially Equivalent | |
| K241972 | BLUEDIAMOND IMPLANT | DZE | Substantially Equivalent | |
| K234142 | TiGEN Abutment, PMMA Abutment and Scan Healing Abutment | NHA | Substantially Equivalent | |
| K240754 | N2 | EIA | Substantially Equivalent | |
| 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 | Substantially Equivalent | |
| K231967 | ARi ExCon Implant System | DZE | Substantially Equivalent | |
| K223909 | R2GATE Lite TM | LLZ | Substantially Equivalent | |
| K230618 | MegaGen Dental Implant Systems Portfolio - MR Conditional | DZE | Substantially Equivalent | |
| K223339 | Bone Chamber Implant | DZE | Substantially Equivalent | |
| K211556 | N2 | EIA | Substantially Equivalent | |
| K211812 | BLUEDIAMOND IMPLANT, Abutment Screw | DZE | Substantially Equivalent | |
| K222219 | R2 Studio Q/RCT820 | OAS | Substantially Equivalent | |
| K220562 | TiGEN Abutment, ZrGEN Abutment and Scan Healing Abutment | NHA | Substantially Equivalent | |
| K210826 | Healing Abutment, Cover Screw | NHA | Substantially Equivalent | |
| K203808 | Multi-unit Abutment, Multi-unit Angled Abutment | NHA | Substantially Equivalent | |
| K203554 | AnyOne External Implant System | DZE | Substantially Equivalent | |
| K210161 | AnyOne Onestage Implant System | DZE | Substantially Equivalent | |
| K192614 | Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet Abutment | NHA | Substantially Equivalent | |
| K192347 | ST Internal Implant System | DZE | Substantially Equivalent | |
| K182448 | AnyRidge Octa 1 Implant System | DZE | Substantially Equivalent | |
| K191127 | Advanced Intermezzo Implant System | DZE | Substantially Equivalent | |
| K190096 | R2GATE | LLZ | Substantially Equivalent | |
| K150537 | MiNi Internal Implant System | DZE | Substantially Equivalent | |
| K140091 | XPEED ANYRIDGE INTERNAL IMPLANT SYSYEM | DZE | Substantially Equivalent | |
| K131289 | I-GEN | JEY | Substantially Equivalent | |
| K123988 | ANYONETM INTERNAL IMPLANT SYSTEM | DZE | Substantially Equivalent | |
| K123870 | XPEED ANYRIDGE INTERNAL IMPLANT SYSTEM | DZE | Substantially Equivalent | |
| K122231 | XPEED ANY RIDGE INTERNAL IMPLANT SYSTEM | DZE | Substantially Equivalent | |
| K122240 | BONE PLUS BCP EAGLE EYE | LYC | Substantially Equivalent | |
| K090950 | BONE PLUS BCP | LYC | Substantially Equivalent | |
| K081302 | RESCUE EXTERNAL IMPLANT SYSTEM | DZE | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3005554774 | 3005554774 | Megagen Implant Co., Ltd. | 45, Secheon-ro 7-gil, Dasa-eup, Dalseong-gun, Daegu 42921 KR | 2026 | and 7 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- NHAAbutment, Implant, Dental, Endosseous
- NDPAccessories, Implant, Dental, Endosseous
- EGGAttachment, Precision, All
- LYCBone Grafting Material, Synthetic
- EJLBur, Dental
- DZADrill, Dental, Intraoral
- EMJElevator, Surgical, Dental
- EHZEvacuator, Oral Cavity
- NYEFixture Mount Kit
- DZEImplant, Endosseous, Root-Form
- EIYInstrument, Filling, Plastic, Dental
- EMOKnife, Periodontic
- JEYPlate, Bone
- EIHPowder, Porcelain
- LLZSystem, Image Processing, Radiological
- NOFSystem, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations
- EFWToothbrush, Manual
- EHYTray, Impression, Preformed
- EIAUnit, Operative Dental
- OASX-Ray, Tomography, Computed, Dental
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain