Cleared Traditional

K171867 - Dr’s Finder NEO (FDA 510(k) Clearance)

Mar 2018
Decision
281d
Days
-
Risk

K171867 is an FDA 510(k) clearance for the Dr’s Finder NEO. This device is classified as a Locator, Root Apex.

Submitted by Good Doctors Co., Ltd. (Incheon, KR). The FDA issued a Cleared decision on March 30, 2018, 281 days after receiving the submission on June 22, 2017.

This device falls under the Dental FDA review panel.

Submission Details

510(k) Number K171867 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 2017
Decision Date March 30, 2018
Days to Decision 281 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code LQY - Locator, Root Apex
Device Class -