MegaGen Implant
Also known as: MegaGen Implant Co., Ltd., MegaGen
A South Korean implant manufacturer based in Daegu, producing the AnyRidge, AnyOne and BlueDiamond implant systems.
Research in progress. Some fields on this entry are not yet verified against a primary source, so we have left them blank rather than filling them in — and this page is not published to search engines until they are.
Key facts
| Headquarters | Daegu, South Korea (45 Secheon-ro 7-gil, Dasa-eup, Dalseong-gun), with an international sales office in SeoulVerified spec[1] |
|---|---|
| Country | South KoreaVerified spec[1] |
| Founded | Manufacturer documentation not located(Frequently reported as 2002, but not stated on any manufacturer page we were able to reach) |
| Ownership | Not publicly verified(We have not located a primary source setting out the current shareholding) |
| Brand | MegaGen, covering the AnyRidge, AnyOne, BlueDiamond and ARi implant systemsManufacturer-reported[1] |
| Geographic availability | Distributor network across more than 100 countriesManufacturer-reported[1] |
| manufacturingCountry | South KoreaVerified spec[2]Country of the FDA-registered device establishment, which may differ from the brand’s home country. |
Overview
Regulatory record
Read this before drawing conclusions. A clearance or certificate means a device may legally be sold in a market. It is not a finding that the implant performs well, and it is not a comparison against other implants. In particular, FDA "clearance" is not FDA "approval" — clearance means the FDA accepted the device as substantially equivalent to one already on the market. What these actually mean →
FDA 510(k) clearance33 records
Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.
| Number | Device | Holder | Date |
|---|---|---|---|
| K251232 | MegaGen Zygoma Dental Implant System | Megagen Implant Co., Ltd. | 2026-06-18 |
| K242030 | MegaGen Dental Implant Abutment | Megagen Implant Co., Ltd. | 2025-01-13 |
| K241972 | BLUEDIAMOND IMPLANT | Megagen Implant Co., Ltd. | 2024-12-27 |
| K234142 | TiGEN Abutment, PMMA Abutment and Scan Healing Abutment | Megagen Implant Co., Ltd. | 2024-09-18 |
| 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 | Megagen Implant Co., Ltd. | 2024-01-22 |
| K231967 | ARi ExCon Implant System | Megagen Implant Co., Ltd. | 2023-12-07 |
| K230618 | MegaGen Dental Implant Systems Portfolio - MR Conditional | Megagen Implant Co., Ltd. | 2023-10-11 |
| K223339 | Bone Chamber Implant | Megagen Implant Co., Ltd. | 2023-07-18 |
| K211812 | BLUEDIAMOND IMPLANT, Abutment Screw | Megagen Implant Co., Ltd. | 2023-01-06 |
| K220562 | TiGEN Abutment, ZrGEN Abutment and Scan Healing Abutment | Megagen Implant Co., Ltd. | 2022-11-10 |
| K210826 | Healing Abutment, Cover Screw | Megagen Implant Co., Ltd. | 2022-02-03 |
| K203808 | Multi-unit Abutment, Multi-unit Angled Abutment | Megagen Implant Co., Ltd. | 2021-10-20 |
| K203554 | AnyOne External Implant System | Megagen Implant Co., Ltd. | 2021-08-28 |
| K210161 | AnyOne Onestage Implant System | Megagen Implant Co., Ltd. | 2021-06-22 |
| K192614 | Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet Abutment | Megagen Implant Co., Ltd. | 2020-02-13 |
| K192347 | ST Internal Implant System | Megagen Implant Co., Ltd. | 2019-11-14 |
| K182448 | AnyRidge Octa 1 Implant System | Megagen Implant Co., Ltd. | 2019-10-09 |
| K191127 | Advanced Intermezzo Implant System | Megagen Implant Co., Ltd. | 2019-10-08 |
| K150537 | MiNi Internal Implant System | Megagen Implant Co., Ltd. | 2015-07-21 |
| K140091 | XPEED ANYRIDGE INTERNAL IMPLANT SYSYEM | Megagen Implant Co., Ltd. | 2014-12-12 |
| K123988 | ANYONETM INTERNAL IMPLANT SYSTEM | Megagen Implant Co., Ltd. | 2013-08-15 |
| K123870 | XPEED ANYRIDGE INTERNAL IMPLANT SYSTEM | Megagen Implant Co., Ltd. | 2013-03-27 |
| K122231 | XPEED ANY RIDGE INTERNAL IMPLANT SYSTEM | Megagen Implant Co., Ltd. | 2012-10-04 |
| K110955 | ANYRIDGE INTERNAL IMPLANT SYSTEM | Megagen Co., Ltd. | 2011-11-22 |
| K101890 | BALL ABUTMENT SYSTEM | Megagen Co., Ltd. | 2011-02-03 |
| K081302 | RESCUE EXTERNAL IMPLANT SYSTEM | Megagen Implant Co., Ltd. | 2008-08-15 |
| K073058 | RESCUE INTERNAL IMPLANT SYSTEM | Megagen Co., Ltd. | 2008-04-11 |
| K070562 | EZ PLUS IMPLANT SYSTEM | Megagen Co., Ltd. | 2007-05-18 |
| K063216 | RESCUE INTERNAL IMPLANT SYSTEM | Megagen Co., Ltd. | 2007-04-02 |
| K053353 | RESCUE IMPLANT SYSTEM | Megagen Co., Ltd. | 2006-04-19 |
| K053354 | INTERMEZZO PLUS FIXTURE | Megagen Co., Ltd. | 2006-04-13 |
| K052369 | EXFEEL IMPLANT SYSTEM | Megagen Co., Ltd. | 2006-01-10 |
| K051018 | INTERMEZZO IMPLANT SYSTEMS | Megagen Co., Ltd. | 2005-09-02 |
Other3 records
Registered device establishment in South Korea. Registration records where a device is made or handled; it is not a clearance, an approval, or any assessment of the product.
| Number | Device | Holder | Date |
|---|---|---|---|
| 3030089802 | — | MegaGen Implant Co., Ltd. (Research Laboratories) | — |
| 3005554774 | — | Megagen Implant Co., Ltd. | — |
| 1332 device records | — | MegaGen Implant | — |
Clearance records for MegaGen Implant were retrieved from the issuing authority's own database, not from the manufacturer's marketing material. We attribute a clearance to a brand only when the filing holder belongs to that brand's corporate family — third-party clearances for compatible components are excluded, because they belong to the company that made the component, not to MegaGen Implant.
Sources
Numbers match the citations beside each claim above.
Primary sources
- [1]MegaGen Implants — corporate website — MegaGen Implant Co., Ltd.. Accessed 2026-07-21.
- [2]openFDA — Device registrations and listings — US Food and Drug Administration. Accessed 2026-07-22.