Some people complained today that they had problems after wearing the well-known brand Zenyum’s invisible braces, and they also found that the manufacturer was suspected of illegally importing finished braces and competing at low costs. Currently, more than 100 victims have formed a self-help association and will file a consumer protection group lawsuit, expecting to seek compensation of tens of millions of yuan.
Zenyum responded that this is a false accusation and the product is legal and compliant. The Food and Drug Administration of the Ministry of Health and Welfare stated that if dentists use domestically approved software and entrust qualified operators to make braces, it is a legal customized medical device.
Zenyum invisible braces, which claim to be from Singapore, are endorsed by many Taiwanese internet celebrities and entertainment stars, but some people have problems after wearing the braces, including gaps between the front teeth, open bites, gum atrophy, tooth discoloration, and permanent damage. People have found out that the so-called “medical license” of the product is suspected to only import braces raw materials and software, not approved braces finished products.
Ms. Li spent about 70,000 yuan on a one-year and two-month course of treatment, but during the treatment, she found that the lower gums atrophied, causing more than one tooth to be damaged. Ms. Yang said that she was initially arranged by the medical staff of the special clinic to wear 30 sets of braces, but when she wore the 3rd and 4th sets, her tongue was severely cut and her gums were pressed and swollen. Although she reported it to the Zenyum customer service staff, they said that she could use a nail file to grind the braces. This treatment made her feel negative.
Huang Weilin, a lawyer of the Self-Help Association, said that the Ministry of Health and Welfare approved Zenyum to import raw materials, but the company was suspected of manufacturing invisible braces in mainland China and importing them directly to Taiwan with a fake license. Through low costs, the company adopted a price-cutting competition strategy. In addition to being suspected of changing the software, the company also had concerns about violating the “Medical Act”. Correction of teeth should be performed by dentists or dental technicians, but Zenyum’s invisible braces were handed over to unknown people in mainland China.
The self-help group, which consists of more than 100 victims, believes that the business has used the difference in the meaning of the license to confuse the public, suspected of illegally smuggling imports, and sold transparent braces through endorsements by Internet celebrities and entertainment stars with millions of subscribers to make a lot of money. They will file a collective civil lawsuit against the brand and its company to demand tens of millions of yuan in compensation, but the medical staff of the special clinic who performed medical acts are not included in this lawsuit for the time being. If the clinic or medical staff think they are also victims, they can also work with the self-help group to assert their rights. The self-help group also stated that if the Internet celebrities and entertainment stars who endorse the products do not remove the endorsement videos, the self-help group will also investigate.
Zenyum issued a statement earlier that since entering the Taiwan market in 2020, it has always operated in accordance with the law and applied for a medical device license from the Food and Drug Administration of the Ministry of Health and Welfare. All imports and company operations are in compliance with regulations and there is absolutely no violation of the law. Anyone can verify through the FDA’s “Medical Device License Inquiry” system. The license clearly states the product appearance, manufacturing location and manufacturing plant, etc., to ensure that the source of the product is transparent and in compliance with regulations.
Qian Jiahong, deputy director of the Medical Device and Cosmetics Group of the FDA, said that the suspected violations of product supply sources, advertising, etc. revealed by the press conference have been investigated and clarified by the Health Bureau and dealt with in accordance with the law.
Qian Jiahong said that after inquiry, Zenyum invisible braces obtained the “Ministry of Health Medical Device Land Transport No. 001486” license for the “‘Youya’ transparent orthodontic braces system”. The scope of approval is orthodontic dental mold sampling, orthodontic design software and braces materials. The finished transparent braces are not within the scope of the license approval.
Qian Jiahong said that in practice, dentists use the license software to plan orthodontic treatment plans for specific patients. Based on the aforementioned treatment plan, they request license manufacturers to produce transparent orthodontic braces as customized equipment. This is the output of medical personnel performing statutory duties and is a medical business link. The import of such braces does not need to apply for inspection and registration with the central competent authority.
Zenyum pointed out that after the product is diagnosed by a local qualified dentist, it is exclusively planned and designed for a specific single patient. It is a customized medical device and is legally imported into Taiwan. It does not need to be processed and manufactured by domestic dental technicians and can be used legally. We emphasize that we have been operating in Taiwan for many years, and the competent authorities and customs have never accused our products of illegal imports, which fully proves their legality. We will continue to strictly abide by the law to ensure the legality and safety of our products.
Zenyum emphasizes that market competition should be based on professionalism and integrity, rather than influencing consumer decisions through false accusations. We have taken legal action against those who have the intention to spread rumors and smear, and will never tolerate any behavior that deliberately spreads false information and affects market order.
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