Cleared Special

K070246 - DOWN PAK

K070246 is an FDA 510(k) clearance for DOWN PAK, manufactured by Endo Twinn B.V.. The device is a Class 1 Dental device with product code EKM cleared through the Special 510(k) pathway after a 22-day FDA review.

K070246 · Endo Twinn B.V. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2007
Decision
22d
Days
Class 1
Risk

K070246 is an FDA 510(k) clearance for the DOWN PAK. Classified as Gutta-percha (product code EKM), Class I - General Controls.

Submitted by Endo Twinn B.V. (Amsterdam, NL). The FDA issued a Cleared decision on February 16, 2007 after a review of 22 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3850 - the FDA dental device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K070246

510(k) Number K070246 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 2007
Decision Date February 16, 2007
Days to Decision 22 days
Submission Type Special
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
106d faster than avg
Panel avg: 128d · This submission: 22d
Pathway characteristics
Modification to existing cleared device.

EKM Device Classification - Class 1, General Controls

Product Code EKM Gutta-percha
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.3850
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - EKM Gutta-percha

All 22
Devices cleared under the same product code (EKM) and FDA review panel - the closest regulatory comparables to K070246.
EI DOWNPAK BARRIER SLEEVES
K073369 · Hu-Friedy Mfg. Co., Inc. · Feb 2008
TGP (GUTTA PERCHA CONTAINING TETRACYCLINE OR DOXYCYCLINE)
K051573 · Dr. Howard Martin, P.A. · Jun 2006
ENDO TWINN
K042870 · Endo Twinn B.V. · Jan 2005
FIBERFILL SGP
K023819 · Pentron Clinical Technologies · Mar 2003
ANTIBACTERIAL GUTTA PERCHA
K971641 · Dr. Howard Martin, P.A. · Jul 1997
THERMAPREP PLUS OVEN
K970134 · Tulsa Dental Products, Ltd. · Mar 1997
K070246 · DOWN PAK
Download PDF FDA Summary Endo Twinn B.V.