Cleared Traditional

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

K171867 · Good Doctors Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2018
Decision
281d
Days
-
Risk

K171867 is an FDA 510(k) clearance for the Dr’s Finder NEO. Classified as Locator, Root Apex (product code LQY).

Submitted by Good Doctors Co., Ltd. (Incheon, KR). The FDA issued a Cleared decision on March 30, 2018 after a review of 281 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

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
154d slower than avg
Panel avg: 127d · This submission: 281d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LQY Locator, Root Apex
Device Class -

Regulatory Consultant

LK Consulting Group USA, Inc.
Priscilla Chung

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.