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MegaGen MiNi

Also known as: MiNi, MegaGen MiNi Implant

MegaGen’s narrow-diameter implant, made in Ø3.0 and Ø3.25 mm for narrow ridges and small anterior teeth, with a separate one-piece overdenture variant.

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.

Quick facts

ManufacturerMegaGen Implant Co., Ltd.Manufacturer-reported[1][2]
Body geometryTapered fixture with a straight 3 mm coronal sectionManufacturer-reported[1]
Thread designThread pitch 0.6 mm, with thread depth of 0.2 mm at Ø3.0 and 0.3 mm at Ø3.25Manufacturer-reported[1]
Apex designApex diameter 1.8 mm at Ø3.0 and 2.0 mm at Ø3.25Manufacturer-reported[1]
MaterialManufacturer documentation not located
SurfaceManufacturer documentation not located
ConnectionInternal connection of 2.3 mm diameter with a 1.7 mm hex and an M1.4 abutment screwManufacturer-reported[1]
Available diametersØ3.0 and Ø3.25 mm, with platform diameters of 2.6 mm and 2.8 mm respectivelyManufacturer-reported[1]
Available lengths8.0, 9.5, 11.0, 12.5 and 14.5 mmManufacturer-reported[1]

Overview

The MegaGen MiNi catalogue actually contains two different products, and confusing them is easy. The MiNi fixture proper is a two-piece implant in Ø3.0 and Ø3.25 mm with a conventional internal connection and a separate abutment; the MiNi Overdenture range in the same document is a set of one-piece fixtures with an integral cuff and post, made to retain a denture. Only the second of these is a “mini implant” in the sense most patients mean. Neither is a substitute for a standard-diameter implant in a load-bearing posterior site, and narrow implants generally carry their own literature on fracture risk.

Clinical positioning

What the manufacturer says this system is designed for. This is not the same thing as independent clinical evidence, which is set out separately below.

Presented by MegaGen for narrow ridges and small anterior teeth; a separate MiNi Overdenture range of one-piece fixtures in Ø2.5, Ø3.0 and Ø3.5 mm with 2 mm and 4 mm cuffs and lengths of 8.5, 10.0, 11.5 and 13.0 mm is listed in the same catalogueManufacturer-reported

Further detail

Geographic availabilityRequires manual verification

Clinical evidence

We have not yet completed a system-specific evidence review for MegaGen MiNi. Insufficient system-specific evidence How we grade evidence

Similar implant systems

The clearances below are held by MegaGen at brand level and cover its implant range, not MegaGen MiNi specifically. We show them here because that is the level at which regulators actually issue them.

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) clearance8 records

Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.

NumberDeviceHolderDate
K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd.2026-06-18
K242030MegaGen Dental Implant AbutmentMegagen Implant Co., Ltd.2025-01-13
K233450MegaGen 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 ScrewMegagen Implant Co., Ltd.2024-01-22
K230618MegaGen Dental Implant Systems Portfolio - MR ConditionalMegagen Implant Co., Ltd.2023-10-11
K182448AnyRidge Octa 1 Implant SystemMegagen Implant Co., Ltd.2019-10-09
K140091XPEED ANYRIDGE INTERNAL IMPLANT SYSYEMMegagen Implant Co., Ltd.2014-12-12
K123870XPEED ANYRIDGE INTERNAL IMPLANT SYSTEMMegagen Implant Co., Ltd.2013-03-27
K110955ANYRIDGE INTERNAL IMPLANT SYSTEMMegagen Co., Ltd.2011-11-22

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.

NumberDeviceHolderDate
3030089802MegaGen Implant Co., Ltd. (Research Laboratories)
3005554774Megagen Implant Co., Ltd.
1332 device recordsMegaGen

Clearance records for MegaGen 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.

Sources

Numbers match the citations beside each claim above.

Primary sources

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