Cleared Traditional

K150727 - ESTECEM

K150727 is an FDA 510(k) clearance for ESTECEM, manufactured by Tokuyama Dental Corporation. The device is a Class 2 Dental device with product code EMA cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K150727 · Tokuyama Dental Corporation · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2015
Decision
89d
Days
Class 2
Risk

K150727 is an FDA 510(k) clearance for the ESTECEM. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by Tokuyama Dental Corporation (Tokyo, JP). The FDA issued a Cleared decision on June 17, 2015 after a review of 89 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3275 - 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.

View all Tokuyama Dental Corporation devices

FDA 510(k) Submission Details - K150727

510(k) Number K150727 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 2015
Decision Date June 17, 2015
Days to Decision 89 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 127d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EMA Device Classification - Class 2, Special Controls

Product Code EMA Cement, Dental
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3275
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 - EMA Cement, Dental

All 318
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K150727.
TheraCem
K161256 · Bisco, Inc. · Jul 2016
G-Cem LinkForce, Dual Cure Activator, Try-In Paste, Multi Primer
K153231 · GC America, Inc. · Jul 2016
PANAVIA V5: Standard Kit (Universal (A2)), Standard Kit (Clear), Introductory Kit (Universal (A2)), Introductory Kit (Clear), Sample Pack (Universal (A2)), Paste (Universal (A2)), Paste (Clear), Paste (Brown (A4)), Paste (White), Paste (Opaque), Try-in Paste (Universal (A2)), Try-in Paste (Clear), Try-in Paste (Brown (A4)), Try-in Paste (White), Try-in Paste (Opaque), Tooth Primer
K150704 · Kuraray Noritake Dental, Inc. · Aug 2015
Bifix Temp
K143212 · Voco GmbH · May 2015
PANAVIA SA Cement Plus Handmix
K142623 · Kuraray Noritake Dental, Inc. · Feb 2015
PANAVIA SA Cement Plus Automix
K142625 · Kuraray Noritake Dental, Inc. · Jan 2015