U.S. International Trade Commission Receives Complaint on Clear Aligners and Components
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On November 19, 2025, the U.S. International Trade Commission (USITC) announced that it has received a new complaint. The complaint is titled “Certain Clear Aligners and Components Thereof,” Docket Number 3850.
The complaint was filed by Align Technology, Inc. on September 23, 2025. It claims that some companies have violated section 337 of the Tariff Act of 1930. Align Technology, Inc. says that certain clear aligners and their parts are being brought into the United States, sold for import, and sold within the U.S. after being imported, in a way that breaks the law.
The companies named as respondents in the complaint are:
- Angelalign Technology Inc. of China
- Wuxi EA Medical Instruments Technologies Co., Ltd. of China
- Wuxi EA Bio-Tech Co., Ltd. of China
- Shanghai EA Medical Instruments Co., Ltd. of China
- USA Angelalign Technology Corp. of Newark, Delaware
Align Technology, Inc. is asking the Commission to issue a limited exclusion order. They also ask for cease and desist orders, and they want a bond put in place on the products while the matter is under the 60-day Presidential review.
The original notice was published on September 25, 2025. Because of a lapse in appropriations, the Commission could not accept public submissions at that time. Now, the Commission has changed the notice and is asking for public comments about the complaint and any issues that may affect the public interest.
The Commission is accepting comments from the public, interested parties, and government agencies. Comments should focus on whether the requested actions by the complainant would affect:
- Public health and welfare in the United States
- Competition in the U.S. economy
- Production of similar items in the U.S.
- U.S. consumers
The Commission is especially interested in comments that:
- Explain how the products could be used in the U.S.
- Identify any health, safety, or welfare concerns in the U.S. if the orders are given.
- Identify products made by the complainant or others in the U.S. that could replace these products.
- Indicate if the complainant, its licensees, or third parties can make enough products to replace those that might be excluded, in a reasonable time.
- Explain how the requested orders would affect U.S. consumers.
Comments about the public interest must be sent in by close of business, eight calendar days after this notice appears in the Federal Register. Other written submissions about this matter must also be filed by that deadline. If there are replies to comments, they must be filed within three calendar days after the initial comments were due. No other submissions will be accepted unless the Commission asks for them. Each submission or reply can be up to five pages long, including any attachments.
Anyone sending their comments must file the original document electronically using the Commission’s Electronic Document Information System (EDIS) at https://edis.usitc.gov. Only electronic filings are being accepted at this time. No paper documents will be accepted until further notice.
If someone wants to submit confidential information, a request for confidential treatment must be included. Requests should explain why the information should stay confidential and be sent to the Secretary to the Commission. The Commission will handle all such requests as outlined in 19 CFR 201.6.
All non-confidential submissions will be public and can be viewed on the EDIS website.
This action comes under section 337 of the Tariff Act of 1930, as amended, and rules 201.10 and 210.8(c) of the Commission’s Rules of Practice and Procedure.
The notice was issued by Lisa Barton, Secretary to the Commission, on November 17, 2025.
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