Styptin, Hemogin-L, Hemodettes, and GingiGEL Aluminum Chloride Impregnated Retraction Cord/Materials (K162948) - FDA 510(k) Clearance

K162948 is an FDA 510(k) clearance for the Styptin, Hemogin-L, Hemodettes, and GingiGEL Aluminum Chloride Impregnated Re.... Classified as Cord, Retraction (product code MVL).

Submitted by Kerr Corporation (Orange, US). The FDA issued a Cleared decision on August 8, 2017 after a review of 291 days - an extended review cycle.

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.

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