Software Snag Causes Dental Device Firm to Draw a Warning Letter

Vitang Technology, a Tustin, Calif.-based manufacturer of 3D printed dental alignment devices, failed to seek the FDA’s clearance when it changed the software used with its UniSmile Clear Aligner, the agency said in a June 12 warning letter to the company.

An FDA investigator observed the software issue along with numerous quality system lapses during a Jan. 24-31 inspection.

In response to the inspection observations, Vitang said it had performed verification and validation activities on the new software and concluded that it was “similar in designing clear aligner treatment plans.” But the agency noted that the change “has the potential to affect the proposed treatment protocol as well as the dimensions, configurations, and applied forces of the UniSmile Clear Aligners, and affect the clinical outcome.”

The FDA also rapped the company for claims on its website that the UniSmile dental alignment system was “FDA APPROVED” and for using the agency’s logo.

“Statements about having active status with the FDA, and display of the FDA logo near images of and information about the respective products, is misleading,” the warning letter said, adding that the “presentation conveys the misimpression” that the products have been reviewed and approved by the FDA.

Read the warning letter here.

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