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

Submission Details

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.

Device Classification

Product Code LQY Locator, Root Apex
Device Class -

Regulatory Peers - LQY Locator, Root Apex

All 19
Devices cleared under the same product code (LQY) and FDA review panel - the closest regulatory comparables to K131907.
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
MULTIPLE (APEX LOCATOR), MODEL RCM-7
K090925 · J. Morita USA, Inc. · Nov 2009
DENTA PORT
K022147 · J. Morita USA, Inc. · Dec 2002
FORAMATRON V, MODEL D680
K002195 · Parkell, Inc. · Aug 2000