Cleared Traditional

K113608 - DEFLEX

K113608 is an FDA 510(k) clearance for DEFLEX, manufactured by Nuxen S.R.L.. The device is a Class 2 Dental device with product code EBI cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K113608 · Nuxen S.R.L. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2012
Decision
126d
Days
Class 2
Risk

K113608 is an FDA 510(k) clearance for the DEFLEX. Classified as Resin, Denture, Relining, Repairing, Rebasing (product code EBI), Class II - Special Controls.

Submitted by Nuxen S.R.L. (Buenos Aires, AR). The FDA issued a Cleared decision on April 10, 2012 after a review of 126 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3760 - 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: 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.

FDA 510(k) Submission Details - K113608

510(k) Number K113608 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 2011
Decision Date April 10, 2012
Days to Decision 126 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
2d faster than avg
Panel avg: 128d · This submission: 126d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBI Device Classification - Class 2, Special Controls

Product Code EBI Resin, Denture, Relining, Repairing, Rebasing
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3760
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - EBI Resin, Denture, Relining, Repairing, Rebasing

All 303
Devices cleared under the same product code (EBI) and FDA review panel - the closest regulatory comparables to K113608.
VERTEX THERMOSENS RIGID
K123220 · Vertex-Dental B.V. · Mar 2013
I.FLEX BY TCS
K123396 · Thermoplastic Comfort Systems, Inc. · Jan 2013
QUARTZ SPLINT SYSTEM (UD, WOVEN, ROPE, MESH) QUARTZ SPINT RESIN QS FLOW
K122348 · Recherches Techniques Dentaires (R.T.D.) · Oct 2012
DEFLEX ACRILATO
K113788 · Nuxen S.R.L. · Mar 2012
FOUNDATION DENTAL RESIN
K111709 · Unix-Japan Co., Ltd. · Nov 2011
ORTHO-JET CRYSTAL
K112397 · Lang Dental Mfg. Co., Inc. · Nov 2011
K113608 · DEFLEX
Download PDF FDA Summary Nuxen S.R.L.