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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 30 of 188| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Multi-unit Abutment Package | MUAAON1745 | FDA UDI | Class II | Active |
| XPEED AnyRidge Internal Fixture | AR406010 | FDA UDI | Class II | Active |
| Guide Pin | RIOG100 | FDA UDI | Class I | Active |
| ExFeel External Fixture | RDR3708 | FDA UDI | Class II | Active |
| Bottom Drill | TCMBDL33 | FDA UDI | Class I | Active |
| Stopper Drill | SD2810M | FDA UDI | Class I | Active |
| Healing Cap | AXHC506 | FDA UDI | Class II | Active |
| Multi-unit Angled Abutment | MUAAEH1740 | FDA UDI | Class II | Active |
| Stopper Drill | AROSD3908M | FDA UDI | Class I | Active |
| Diamond Drill | 2DD2025 | FDA UDI | Class I | Active |
| Cover Screw | STCSS | FDA UDI | Class II | Active |
| TiGEN Abutment | NOTW1220 | FDA UDI | Class II | Active |
| ExFeel External Fixture | RDR4011 | FDA UDI | Class II | Active |
| Ball Abutment | AANBAF0000 | FDA UDI | Class II | Active |
| Temporary Abutment | ARTAH3845310 | FDA UDI | Class II | Active |
| Solid Abutment | AANSAL5047 | FDA UDI | Class II | Active |
| EZ Post | EP5545H | FDA UDI | Class II | Active |
| Surgical Kit | KARO3003 | FDA UDI | Class I | Active |
| Healing Abutment | AROHMN45603 | FDA UDI | Class II | Active |
| Impression Coping | BDICPNB4012 | FDA UDI | Class I | Active |
| Kit Case | KAGNS2000 | FDA UDI | Class I | Active |
| AnyOne Onestage Fixture | OSF5010SD | FDA UDI | Class II | Active |
| Scan Abutment | ARICSS3405 | FDA UDI | Class I | Active |
| Angled Abutment | AROAAON5325 | FDA UDI | Class II | Active |
| Healing Abutment | AROHAR704 | FDA UDI | Class II | Active |
| EZ Post Abutment | STEAS4751 | FDA UDI | Class II | Active |
| Milling Abutment | LWCN619 | FDA UDI | Class II | Active |
| Solid Abutment | AANSAL7037 | FDA UDI | Class II | Active |
| Healing Abutment | AROHMR60805 | FDA UDI | Class II | Active |
| Solid Post Cap | ISPC703 | FDA UDI | Class II | Active |
| Ratchet Extension | MERD100L | FDA UDI | Class I | Active |
| Milling Abutment | LWCH619 | FDA UDI | Class II | Active |
| Shaping Drill | TTSSD6418 | FDA UDI | Class I | Active |
| Bottom Drill | TCMBDL28 | FDA UDI | Class I | Active |
| TiGEN Abutment | AROTGRM1214.MTN | FDA UDI | Class II | Active |
| Healing Cap | REC600 | FDA UDI | Class II | Active |
| Surgical Kit | MIK3000 | FDA UDI | Class I | Active |
| Stopper Drill | R2DS5311 | FDA UDI | Class I | Active |
| AXA Abutment | AXARS57420 | FDA UDI | Class II | Active |
| ST Internal Fixture | ST5010D | FDA UDI | Class II | Active |
| AXA Abutment | AXARS53600 | FDA UDI | Class II | Active |
| Drill Stopper | SCDS07 | FDA UDI | Class I | Active |
| Meg-Rhein Package | RCYP | EUDAMEDFDA UDI | Class I | Active |
| EZ Post Abutment | AOOEPN5014 | FDA UDI | Class II | Active |
| i-Gen Screw | IA1620 | FDA UDI | Class II | Active |
| Angled Abutment | AANAAH4215 | FDA UDI | Class II | Active |
| Screw Remover Guide | SRGS22M | FDA UDI | Class I | Active |
| Insert Driver | MID090L | FDA UDI | Class I | Active |
| Solid Abutment | SL55354 | FDA UDI | Class II | Active |
| Analog Connector | TANFLACS5006 | FDA UDI | Class I | Active |