K162662 - GingiDent Gingival Retraction Paste (FDA 510(k) Clearance)

K162662 is an FDA 510(k) clearance for the GingiDent Gingival Retraction Paste. Classified as Cord, Retraction (product code MVL).

Submitted by Pac-Dent International, Inc. (Brea, US). The FDA issued a Cleared decision on October 20, 2017 after a review of 389 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Pac-Dent International, Inc. devices