Cleared Traditional

K131907 - RAYPEX 6

K131907 · Dentsply International, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2014
Decision
219d
Days
-
Risk

K131907 is an FDA 510(k) clearance for the RAYPEX 6. Classified as Locator, Root Apex (product code LQY).

Submitted by Dentsply International, Inc. (York, US). The FDA issued a Cleared decision on January 31, 2014 after a review of 219 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 Dentsply International, Inc. devices

FDA 510(k) Submission Details - K131907

510(k) Number K131907 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 2013
Decision Date January 31, 2014
Days to Decision 219 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
92d slower than avg
Panel avg: 127d · This submission: 219d
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 29
Devices cleared under the same product code (LQY) and FDA review panel - the closest regulatory comparables to K131907.
Apex Locator, DPEX III
K181087 · Guilin Woodpecker Medical Instrument Co., Ltd. · Dec 2018
Dr’s Finder NEO
K171867 · Good Doctors Co., Ltd. · Mar 2018
Dr's Finder
K151274 · Good Doctors Co., Ltd. · Feb 2016
DETECT
K121206 · Forum Engineering Technologies, Ltd. · Jan 2013
I-ROOT 100
K112508 · S-Denti Co., Ltd. · Jun 2012
IROOT 100 MINI
K112153 · S-Denti Co., Ltd. · Apr 2012