Cleared Traditional

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

Feb 2016
Decision
267d
Days
-
Risk

K151274 is an FDA 510(k) clearance for the Dr's Finder. This device is classified as a Locator, Root Apex.

Submitted by Good Doctors Co., Ltd. (Incheon, KR). The FDA issued a Cleared decision on February 4, 2016, 267 days after receiving the submission on May 13, 2015.

This device falls under the Dental FDA review panel.

Submission Details

510(k) Number K151274 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 2015
Decision Date February 04, 2016
Days to Decision 267 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code LQY - Locator, Root Apex
Device Class -