ASIGA PTY LTD

ASIGA PTY LTD produces dental devices, specifically the Asiga DentaBASE and DentaTOOTH, which are intended for use in dental procedures. This conclusion follows directly from the device summary that lists those two products as the company's offerings.

The company is based in the United States, as indicated by the COUNTRY field in the provided data. No other location is mentioned, so the United States is the only confirmed headquarters location.

Both the Asiga DentaBASE and DentaTOOTH are listed in the FDA 510(k) registry. The LISTED IN field explicitly names "fda_510k," confirming that the devices have been submitted to that specific FDA pathway.

The devices are classified as Class II medical devices. This classification is stated in the DEVICE CLASSES field, indicating they are moderate‑risk devices that typically require special controls and FDA 510(k) clearance.

The devices are listed in the FDA 510(k) registry, which means each device has undergone the FDA's 510(k) submission process. This does not imply company‑wide approval; rather, each individual device has been evaluated for clearance under that pathway.