Cortex Dental Implants Industries Ltd.

Cortex Dental Implants Industries Ltd. specializes in dental and maxillofacial devices, primarily focusing on ceramic dental appliance fabrication materials and reusable, non-medicated surgical kits. Their product range includes implant systems (such as conical, hexagonal, and conical-concave designs), short-term and long-term abutments, analogs, healing caps, CAD/CAM abutments, and prosthetic attachments like ball attachments and multi-unit abutments. These devices support dental implantology procedures and prosthetic fabrication.

The company is headquartered in Israel, as indicated in its regulatory and product documentation. This location is relevant for understanding compliance frameworks, such as EU MDR or FDA regulations, that may apply to its devices depending on market distribution.

Cortex Dental Implants Industries Ltd.’s devices are registered in EUDAMED, the European Union’s medical device registry, and the FDA’s 510(k) database, reflecting their presence in both European and U.S. markets. These registries track authorized devices under their respective regulatory schemes (EU MDR and FDA 510(k) clearance).

Under EU Medical Device Regulations, Cortex’s devices fall into Class I, Class IIa, and Class IIb classifications, which determine risk levels and regulatory requirements. For the FDA, corresponding devices are submitted via the 510(k) pathway, a premarket submission to demonstrate substantial equivalence to a legally marketed predicate device. Classification depends on factors like intended use, risk, and patient contact duration (e.g., short-term vs. long-term implants).