Digital Dental Laboratories, Inc

Digital Dental Laboratories, Inc specializes in orthodontic devices, which are used primarily in dental treatments to align teeth and manage jaw development. Their product range includes metal orthodontic brackets for braces, self-removable palate expanders and aligners (such as the Super Spring Speed Aligner), space maintainers for children, orthodontic tubes for archwires, and retainers like the Essex or acrylic-pad types. These devices are designed to support orthodontic treatment by correcting tooth positioning or maintaining space in the mouth.

The company is headquartered in the United States. While the exact location isn’t specified, its operations are based within the country, where it manufactures and distributes its orthodontic devices.

Digital Dental Laboratories, Inc’s devices are listed in the FDA’s UDI (Unique Device Identification) database. This registry ensures traceability and transparency of medical devices by assigning a unique identifier to each product, which helps in tracking and monitoring devices throughout their lifecycle.

All devices produced by Digital Dental Laboratories, Inc fall under Class I regulatory classification in the US. This classification applies to devices that pose minimal risk to patients, such as many orthodontic appliances, which are generally considered low-risk and subject to fewer regulatory controls. Class I devices typically require compliance with general controls, such as proper labeling and manufacturing practices, but do not require pre-market approval.