Cleared Traditional

K123220 - VERTEX THERMOSENS RIGID

K123220 is an FDA 510(k) clearance for VERTEX THERMOSENS RIGID, manufactured by Vertex-Dental B.V.. The device is a Class 2 Dental device with product code EBI cleared through the Traditional 510(k) pathway after a 137-day FDA review.

K123220 · Vertex-Dental B.V. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2013
Decision
137d
Days
Class 2
Risk

K123220 is an FDA 510(k) clearance for the VERTEX THERMOSENS RIGID. Classified as Resin, Denture, Relining, Repairing, Rebasing (product code EBI), Class II - Special Controls.

Submitted by Vertex-Dental B.V. (Charlestown, US). The FDA issued a Cleared decision on March 1, 2013 after a review of 137 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.

View all Vertex-Dental B.V. devices

FDA 510(k) Submission Details - K123220

510(k) Number K123220 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 2012
Decision Date March 01, 2013
Days to Decision 137 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
9d slower than avg
Panel avg: 128d · This submission: 137d
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 277
Devices cleared under the same product code (EBI) and FDA review panel - the closest regulatory comparables to K123220.
PROMOLUX, PROMOLUX HI, WEROPRESS, PREMECO PCS
K130076 · Merz Dental GmbH · Aug 2013
ACRYTONE, REZEN NF, AND ISO FAST DENTURE RESINS
K130680 · Dentsoll, Inc. · Jul 2013
YAMAHACHI DENTURE BASE RESINS
K131036 · Yamahachi Dental Manufacturing Co. · Jul 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
K113608 · Nuxen S.R.L. · Apr 2012