For teeth straightening, see a doctor with orthodontic qualifications for an in-person exam and keep your follow-up visits; don't buy aligners online and wear them at home on your own

Cost

Compared with buying online, there is the extra cost of registration and follow-up visits, and a trip to the clinic every so often. The hard part is that treatment often lasts a year or two, and you have to keep going to the follow-ups.

What you get

The 2022 Guidance for the Registration Review of Clear Aligners (《无托槽矫治器注册审查指导原则》) from the Center for Medical Device Evaluation of the National Medical Products Administration (国家药监局医疗器械技术审评中心) says this kind of aligner has a “management category of Class II.” It requires the instructions to state that “during treatment, wear it under the guidance of a doctor with professional orthodontic qualifications,” and to include “requirements for eating, brushing and regular follow-up visits.” The product name “should not contain empty, hypothetical conceptual names such as ‘invisible’ (“隐形”).” The U.S. Food and Drug Administration (FDA) says: “The FDA has not authorized clear aligners that are sold directly to consumers without a prescription and supervision by a dentist or orthodontist,” meaning that it has not approved a single clear aligner sold directly to individuals without a dentist's prescription and supervision. The FDA also says: “In-person examination by a dentist or orthodontist can help lower the risks of uneven bite, unintended tooth movement, pain, and tooth loss,” that is, an in-person exam by a dentist can lower the risks of an uneven bite, teeth moving out of place, pain and tooth loss. Regular in-person follow-up after you start wearing them is what confirms the teeth are moving safely as planned. Both are regulatory documents and give no rate of incidents.

Notes

The size of the benefit is rated small because no rate of incidents was found, and the judgment can only be made from the consequences. No risk notice from Chinese drug regulators or health departments about “buying aligners online and wearing them at home yourself” was found, so this item rests mainly on the registration requirements and what the FDA says. Orthodontics is a medical procedure. For teeth straightening that is medical cosmetology in nature, the facility's license must list the matching specialty and the doctor doing it must be qualified; for how to check, see §28.2 (facility license and attending physician). A 2023 notice on dental care from four government departments also names unlicensed facilities and hiring non-health-technical staff to treat teeth as things to be severely punished. Medical insurance does not cover orthodontics; see §24.12 (ask what a dental implant package includes before you get one).

Evidence grade

C : The author's experience or common practice, without direct literature.

Sources

1. 国家药品监督管理局医疗器械技术审评中心 (2022). 无托槽矫治器注册审查指导原则（2022 年第 41 号）. https://www.cmde.org.cn/flfg/zdyz/zdyzwbk/20230103095116100.html
2. 国家卫生健康委办公厅等 (2023). 关于进一步推进口腔医疗服务和保障管理工作的通知（国卫办医政发〔2023〕11 号，第五条）. https://www.gov.cn/zhengce/zhengceku/202309/content_6903786.htm
3. U.S. Food and Drug Administration (2026). Clear Dental Aligners（页面 2026 年 9 月 9 日更新）. https://www.fda.gov/medical-devices/dental-devices/clear-dental-aligners

Translated from the Chinese original. Original book, section 28, tip 9. This section is about health and medicines. It is general information, not a substitute for a doctor’s diagnosis or prescription. Content may be out of date and rules differ by place. When you actually deal with an agency, a doctor or a court, follow what local officials, doctors and lawyers tell you. Disclaimer