Vista FS, Vista FS Liquid (K190220) - FDA 510(k) Clearance

K190220 is an FDA 510(k) clearance for the Vista FS, Vista FS Liquid. Classified as Cord, Retraction (product code MVL).

Submitted by Inter-Med/Vista Dental Products (Racine, US). The FDA issued a Cleared decision on June 10, 2019 after a review of 125 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel. 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.

View all Inter-Med/Vista Dental Products devices