Cleared Traditional

K151274 - Dr's Finder

K151274 · Good Doctors Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2016
Decision
267d
Days
-
Risk

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

FDA 510(k) Submission Details - K151274

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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
140d slower than avg
Panel avg: 127d · This submission: 267d
Pathway characteristics
Predicate-based equivalence.

LQY Device Classification - Class 0,

Product Code LQY Locator, Root Apex
Device Class -

Regulatory Peers - LQY Locator, Root Apex

All 20
Devices cleared under the same product code (LQY) and FDA review panel - the closest regulatory comparables to K151274.
Propex IQ Apex Locator
K191806 · Dentsply Sirona · Oct 2019
Apex Locator, DPEX III
K181087 · Guilin Woodpecker Medical Instrument Co., Ltd. · Dec 2018
Dr’s Finder NEO
K171867 · Good Doctors Co., Ltd. · Mar 2018
RAYPEX 6
K131907 · Dentsply International, Inc. · Jan 2014
MULTIPLE (APEX LOCATOR), MODEL RCM-7
K090925 · J. Morita USA, Inc. · Nov 2009
DENTA PORT
K022147 · J. Morita USA, Inc. · Dec 2002