Cleared Traditional

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

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

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
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.

Device Classification

Product Code LQY Locator, Root Apex
Device Class -