Aproxi Aps
DK Last updated 22 Oct 2026
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- Devices
- 1
- Registries
- FDA 510(k)
- FDA recalls
- 0
Catalogue
Aproxi 1100 And 4000 Series Dental Inlays Ref K073047
What Aproxi Aps makes
Aproxi Aps manufactures dental inlays, including the APROXI 1100 and 4000 Series, designed for restorative procedures in dentistry.
These devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Frequently asked questions
What types of medical devices does Aproxi Aps manufacture?
Aproxi Aps specializes in dental inlays, specifically the APROXI 1100 and 4000 Series. These devices are intended for use in restorative dental procedures, helping to repair and restore damaged teeth.
Where is Aproxi Aps based?
Aproxi Aps is headquartered in the United States. The company’s location is relevant for understanding its regulatory framework and operational reach.
How are Aproxi Aps’s devices classified under FDA regulations?
Aproxi Aps’s dental inlays, such as the APROXI 1100 and 4000 Series, are classified as Class II devices under FDA regulations. This classification is based on their intended use in restorative dentistry, where they pose moderate risk and require special controls to ensure safety and effectiveness.
Which regulatory registries or databases list Aproxi Aps’s devices?
Aproxi Aps’s devices, including the APROXI 1100 and 4000 Series, are listed in the FDA’s 510(k) registry. This pathway demonstrates that the devices have undergone a premarket notification process to show substantial equivalence to a legally marketed predicate device, ensuring compliance with FDA requirements.
Information
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- DK