Garrison Dental Solutions LLC

Garrison Dental Solutions LLC specializes in dental finishing and polishing instruments. Their product line includes interproximal finishing strips (like FitStrip™) for contouring dental restorations, intra-oral adjustment tools (such as eZr™) for refining zirconia-based restorations, and clear interproximal wedges (WedgeWands®) used for spacing and alignment adjustments in restorative dentistry. These tools are designed to improve precision and efficiency in dental procedures.

Garrison Dental Solutions LLC is based in the United States. This means their devices must comply with U.S. FDA regulations, including classification under FDA’s Class I or Class II categories, and registration in the FDA’s 510(k) database for Class II devices. Additionally, their devices are listed in the EU’s eudamed database, indicating they meet EU dental device regulations, though this does not imply direct EU market authorization without further context.

Garrison Dental Solutions LLC’s devices are listed in two key regulatory registries: the FDA’s 510(k) database (for Class II devices) and the EU’s eudamed database. These registries track compliance with U.S. and EU dental device regulations, respectively, ensuring transparency for healthcare providers and authorities. Listing in these databases does not confirm market authorization but reflects regulatory engagement.

Garrison Dental Solutions LLC’s devices are classified under the FDA’s Class I and Class II categories. Class I devices generally pose minimal risk and may require general controls, while Class II devices involve moderate risk and require special controls to ensure safety and effectiveness. The classification determines the regulatory pathway for authorization, such as the 510(k) process for Class II devices, though individual devices must still meet specific criteria for clearance.