K181580 - Cortex CAD/CAM Abutments (FDA 510(k) Clearance)

K181580 is an FDA 510(k) clearance for the Cortex CAD/CAM Abutments. Classified as Abutment, Implant, Dental, Endosseous within the NHA classification (a category for dental implant abutments and prosthetic components), Class II - Special Controls.

Submitted by Cortex Dental Implants Industries , Ltd. (Shlomi, IL). The FDA issued a Cleared decision on January 29, 2019 after a review of 228 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3630 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.