Cleared Traditional

K042870 - ENDO TWINN

K042870 is an FDA 510(k) clearance for ENDO TWINN, manufactured by Endo Twinn B.V.. The device is a Class 1 Dental device with product code EKM cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K042870 · Endo Twinn B.V. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2005
Decision
85d
Days
Class 1
Risk

K042870 is an FDA 510(k) clearance for the ENDO TWINN. 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 January 11, 2005 after a review of 85 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K042870

510(k) Number K042870 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 2004
Decision Date January 11, 2005
Days to Decision 85 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 128d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. Third-party reviewed.

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 Consultant

Kema Quality B.V.
J.A. VAN VUGT

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - EKM Gutta-percha

All 22
Devices cleared under the same product code (EKM) and FDA review panel - the closest regulatory comparables to K042870.
EI DOWNPAK BARRIER SLEEVES
K073369 · Hu-Friedy Mfg. Co., Inc. · Feb 2008
DOWN PAK
K070246 · Endo Twinn B.V. · Feb 2007
TGP (GUTTA PERCHA CONTAINING TETRACYCLINE OR DOXYCYCLINE)
K051573 · Dr. Howard Martin, P.A. · Jun 2006
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
K042870 · ENDO TWINN
Download PDF FDA Summary Endo Twinn B.V.