Korean implant maker MegaGen Implant has won clearance from the US Food and Drug Administration (FDA) for a zygoma implant and launched it at a US industry conference. It is the first time a South Korean implant company has entered this niche market.
MegaGen Implant received FDA 510(k) clearance for the "MegaGen Zygoma Implant System" in June. The company said the product was officially launched under the name "BLUEDIAMOND ZYGOMA" at MegaGen's North America scientific conference held September 18-19 in Chicago.
Who Zygoma Implants Are For and How They Are Used
Zygoma implants are designed for patients whose upper jawbone (maxilla) has resorbed so severely that no site remains for a conventional implant. Because the implant is anchored at an angle into the comparatively dense zygomatic (cheek) bone instead of the gum bone, treatment is possible without a separate bone graft or sinus-lift procedure.
MegaGen said the product supports both immediate-loading and delayed-loading protocols depending on the patient's condition, and is used within a digital full-arch treatment system spanning diagnosis, surgery, and prosthetics. The move extends the company's long-standing "one-day implant" strategy into more complex edentulous (fully toothless) surgery.
Eighth in the World, After Nobel Biocare and Straumann
Zygoma implants require a highly demanding procedure, so few companies make them. MegaGen is the eighth company worldwide to enter this market, following major players such as Nobel Biocare and Straumann. As the population ages and more patients lose all their teeth while demanding immediate restoration of function, the US zygoma implant market is estimated at roughly 230 billion won a year.
Targeting a US Niche, Without Korean Insurance Coverage
Even within South Korea's implant industry, companies are heading in different directions. Osstem Implant and Dentium have seen their China revenue shrink under the Chinese government's half-price bidding policy. Rather than compete on price, MegaGen carved out a niche in the demanding US market, which few companies can enter. MegaGen said it is South Korea's top implant exporter to Europe and the United States, and that it plans to use this clearance as a springboard to expand cooperation with clinicians abroad.
Zygoma implants are not an unfamiliar procedure in South Korea. Some specialized dental clinics, including oral and maxillofacial surgery departments, have already been performing the procedure for severe cases requiring implants without bone grafting. What this FDA clearance changes is not domestic clinical practice, but MegaGen's US revenue and credibility abroad. Zygoma implants, however, remain a demanding procedure for edentulous patients who fall outside Korea's national health insurance coverage for implants (limited to two implants per patient for those aged 65 and older, with a 30% copay), so the cost burden still falls on patients.