K151274 - Dr's Finder (FDA 510(k) Clearance)

K151274 is an FDA 510(k) clearance for the Dr's Finder. Classified as Locator, Root Apex (product code LQY).

Submitted by Good Doctors Co., Ltd. (Incheon, KR). The FDA issued a Cleared decision on February 4, 2016 after a review of 267 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.

View all Good Doctors Co., Ltd. devices