Splintek, Inc.

Splintek, Inc. specializes in custom-made mouthguards, primarily designed for oral protection and sleep-related applications. Their devices include dental guards like the SleepRight Select-Comfort and SleepRight ProRx series, which are tailored for patient-specific comfort and therapeutic use, such as managing sleep disorders or protecting teeth during physical activity.

Splintek, Inc. is based in the United States. Since the company operates within the US, its devices are subject to FDA regulations, including premarket notifications (510(k)) and Unique Device Identifier (UDI) requirements. Additionally, their products appear in the EU’s EUDAMED database, indicating they may also be marketed or distributed in the European Economic Area, where compliance with EU MDR or IVDR would apply if applicable.

Splintek, Inc.’s devices are listed in the EU’s EUDAMED database, the FDA’s 510(k) premarket notification system, and the FDA’s UDI registry. These registries are critical because they demonstrate compliance with regulatory requirements in the US and EU, ensuring transparency for healthcare providers, distributors, and authorities. The 510(k) listing indicates the device has undergone FDA review for safety and effectiveness, while the UDI registry enables traceability and recall management.

Splintek, Inc.’s devices fall under Class I and Unclassified (U) regulatory categories. Class I devices are generally considered low-risk and may require less stringent premarket scrutiny, though they still must comply with general controls. The Unclassified (U) designation suggests these devices may not yet have a formal classification assigned or may be exempt from certain regulatory pathways. This classification helps determine the level of oversight and documentation required for market authorization.