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Sign in to claim this brandMegagen Implant Co., Ltd.
South Korea·KR-MF-000009885
Last updated September 17, 2026
What Megagen Implant Co., Ltd. makes
Megagen Implant Co., Ltd. manufactures dental and maxillofacial surgical procedure kits, including reusable, non-medicated tools, as well as dental implants and abutment components. Their portfolio includes retentive caps, single-stage and internal dental implants, and specialized implant systems like the ARi ExCon Implant, BLUEDIAMOND Implant Abutment Screw, I-GEN, and the Advanced Intermezzo and AnyOne Onestage Implant Systems.
The company’s devices are classified under EU regulations as Class I, Class II, Class IIa, and Class IIb, with listings in the EUDAMED database and FDA’s 510(k) registry. The manufacturer is based in South Korea.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Megagen Implant Co., Ltd. primarily manufacture?
Megagen Implant Co., Ltd. specializes in dental and maxillofacial surgical tools and implants. Their portfolio includes reusable, non-medicated surgical procedure kits, as well as dental implants and abutment components like retentive caps, single-stage implants (e.g., AnyOne Onestage), and specialized systems such as the ARi ExCon Implant and BLUEDIAMOND Implant Abutment Screw. These devices are designed for oral and maxillofacial procedures.
Where is Megagen Implant Co., Ltd. based, and how does this affect their regulatory listings?
Megagen Implant Co., Ltd. is based in South Korea. Their devices are listed in both the EUDAMED database (for European regulatory oversight) and the FDA’s 510(k) registry (for the US market), reflecting their global manufacturing and compliance with international regulatory requirements for dental implants and surgical tools.
Which regulatory registries list Megagen Implant Co., Ltd.’s devices, and why?
Megagen Implant Co., Ltd.’s devices are listed in eudamed (the EU’s medical device registry) and the FDA’s 510(k) registry (for US pre-market submissions). These listings indicate compliance with EU and US regulatory frameworks, where their products—ranging from Class I tools to Class IIb implants—must meet specific safety and performance standards before authorization.
How are Megagen Implant Co., Ltd.’s devices classified under EU regulations?
Under EU regulations, Megagen Implant Co., Ltd.’s devices span multiple risk-based classes: Class I (low-risk, e.g., reusable surgical kits), Class IIa (moderate risk, e.g., some implant systems), Class IIb (higher-risk, e.g., complex dental implants like the Advanced Intermezzo System), and Class II (general moderate-risk category). Classification determines pre-market evaluation requirements, with higher classes needing stricter clinical data or conformity assessments.
What distinguishes Megagen Implant Co., Ltd.’s dental implant systems from their surgical procedure kits?
Megagen’s dental implant systems (e.g., ANYONETM Internal Implant System, RESCUE External Implant System) are active medical devices designed for permanent integration into bone, requiring rigorous classification (Class II/IIb) due to their invasive nature and long-term patient impact. In contrast, their reusable, non-medicated surgical procedure kits (Class I) are tools for procedures like implant placement but do not interact directly with tissues, reducing their regulatory risk.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- South Korea
- Address
- 45, Secheon-ro 7-gil, Daegu, South Korea
- Website
- imegagen.com
- —
- —
- [email protected]
- Phone
- —
- PRRC Contact
- Jun Hyuk Choi
- EUDAMED SRN
- KR-MF-000009885
- FDA FEI Number
- 3005554774
- DUNS Number
- —
Catalogue (9376)
Page 21 of 188| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Healing Abutment | AROHAN502 | FDA UDI | Class II | Active |
| Tap | R2TD41BLT | FDA UDI | Class I | Active |
| Membrane Elevator001 | TLSME001 | FDA UDI | Class I | Active |
| Surgical Kit Case | KINT2000 | FDA UDI | Class I | Active |
| Healing Abutment | ARIEHAR604 | FDA UDI | Class II | Active |
| XPEED AnyRidge Internal Fixture | FALIHX6511 | FDA UDI | Class II | Active |
| Healing Abutment | STHA409R | FDA UDI | Class II | Active |
| Bone Profiler | AGBP50 | FDA UDI | Class I | Active |
| Healing Abutment | BDHAN407 | FDA UDI | Class II | Active |
| Healing Abutment | RDH503S | FDA UDI | Class II | Active |
| Shaping Drill | MFSD430S | FDA UDI | Class I | Active |
| Healing Abutment | EPHA405 | FDA UDI | Class II | Active |
| Stopper Drill | DT42115AO | FDA UDI | Class I | Active |
| ST Internal Fixture | ST4513 | FDA UDI | Class II | Active |
| Healing Abutment | ARIEHAN354 | FDA UDI | Class II | Active |
| ZrGEN Abutment | STCSS3805 | FDA UDI | Class II | Active |
| Temporary Abutment | BDTARB40510 | FDA UDI | Class II | Active |
| EZ Post Abutment | AROEPR5017 | FDA UDI | Class II | Active |
| Healing Abutment | AROHAR502 | FDA UDI | Class II | Active |
| Stopper Drill | CMSD6908 | FDA UDI | Class I | Active |
| Milling Abutment | AROMAN6039 | FDA UDI | Class II | Active |
| AnyOne External Fixture | EF5015 | FDA UDI | Class II | Active |
| Multi Post Screw | AANMSF | FDA UDI | Class II | Active |
| Solid Post Cap | ISPC553 | FDA UDI | Class II | Active |
| Healing Abutment | AROHSR50653 | FDA UDI | Class II | Active |
| Surgical Kit | MSK3000 | FDA UDI | Class I | Active |
| Healing Abutment | AOHM45605 | FDA UDI | Class II | Active |
| Meg-Ball Abutment | MBMI00 | FDA UDI | Class II | Active |
| AXA Abutment | AXBDRS56420 | FDA UDI | Class II | Active |
| Healing Abutment | AROHSR80905N | FDA UDI | Class II | Active |
| Muliti-unit Angled Abutment | MUAARN3055 | FDA UDI | Class II | Active |
| Healing Abutment | AOHM70905N | FDA UDI | Class II | Active |
| ZrGEN Abutment | AAOIPR4515 | FDA UDI | Class II | Active |
| Scan Healing Abutment | ARNSH5007T | FDA UDI | Class II | Active |
| Healing Abutment | AROHMR80905N | FDA UDI | Class II | Active |
| Set-up Pin | MRTS8010 | FDA UDI | Class I | Active |
| Guide Tube | TCMGTS3204 | FDA UDI | Class I | Active |
| EZ Post Abutment | BDEPRB6025 | FDA UDI | Class II | Active |
| Healing Abutment | AOHS70905N | FDA UDI | Class II | Active |
| Healing Abutment | AROHIR40507N | FDA UDI | Class II | Active |
| Meg-Rhein Overdenture System | IDR04 | FDA UDI | Class II | Active |
| ZrGEN Abutment | ARZXM503825N | FDA UDI | Class II | Active |
| ZrGEN Abutment | ARZXL6016 | FDA UDI | Class II | Active |
| AnyOne Onestage Fixture | OSF4508D | FDA UDI | Class II | Active |
| Multi-unit Angled Abutment | MU50317N | FDA UDI | Class II | Active |
| Solid Abutment | STSAS4740 | FDA UDI | Class II | Active |
| Healing Abutment | AROHAN406 | FDA UDI | Class II | Active |
| Flat Gold cylinder | FGC4012 | FDA UDI | Class II | Active |
| EZ Post Abutment | AROEPR5037 | FDA UDI | Class II | Active |
| Muliti-unit Angled Abutment | MUAAON3065TC | FDA UDI | Class II | Active |