Cleared Traditional

K122421 - TEETHMATE DESENSITZER SET TEETHMATE DESENSITIZER POWDER TEETHMATE DESENSITIZER LIQUID

K122421 is an FDA 510(k) clearance for TEETHMATE DESENSITZER SET TEETHMATE DES..., manufactured by Kuraray Noritake Dental, Inc.. The device is a Class 2 Dental device with product code EJK cleared through the Traditional 510(k) pathway after a 124-day FDA review.

K122421 · Kuraray Noritake Dental, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2012
Decision
124d
Days
Class 2
Risk

K122421 is an FDA 510(k) clearance for the TEETHMATE DESENSITZER SET TEETHMATE DESENSITIZER POWDER TEETHMATE DESENSITIZE.... Classified as Liner, Cavity, Calcium Hydroxide (product code EJK), Class II - Special Controls.

Submitted by Kuraray Noritake Dental, Inc. (Chiyoda-Ku, JP). The FDA issued a Cleared decision on December 11, 2012 after a review of 124 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3250 - 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 Kuraray Noritake Dental, Inc. devices

FDA 510(k) Submission Details - K122421

510(k) Number K122421 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 2012
Decision Date December 11, 2012
Days to Decision 124 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
3d faster than avg
Panel avg: 127d · This submission: 124d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EJK Device Classification - Class 2, Special Controls

Product Code EJK Liner, Cavity, Calcium Hydroxide
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3250
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 - EJK Liner, Cavity, Calcium Hydroxide

All 60
Devices cleared under the same product code (EJK) and FDA review panel - the closest regulatory comparables to K122421.
LC CALCIUMHYDROXIDE LINER
K141047 · S&C Polymer Silicon- Und Composite Spezialitaeten · Apr 2015
BASE IT
K134022 · Spident Co., Ltd. · Jun 2014
TEETHMATE DESENSITIZER SET
K131068 · Kuraray Noritake Dental, Inc. · Aug 2013
NUCAL
K120003 · Pulpdent Corporation · Apr 2012
LIME-LITE II
K113711 · Pulpdent Corporation · Mar 2012
CAVIOS CAVITY LINER
K111668 · Neodental Chemical Products Co., Ltd. · Aug 2011