Cleared Traditional

K142371 - Luminesse PMMA

K142371 is the FDA 510(k) clearance for Luminesse PMMA by Talladium, Inc.. It is a Class 2 Dental device (product code EBG) cleared through the Traditional 510(k) pathway after a 242-day FDA review.

K142371 · Talladium, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2015
Decision
242d
Days
Class 2
Risk

K142371 is an FDA 510(k) clearance for the Luminesse PMMA. Classified as Crown And Bridge, Temporary, Resin (product code EBG), Class II - Special Controls.

Submitted by Talladium, Inc. (Valencia, US). The FDA issued a Cleared decision on April 24, 2015 after a review of 242 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3770 - 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 Talladium, Inc. devices

Submission Details

510(k) Number K142371 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 2014
Decision Date April 24, 2015
Days to Decision 242 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
115d slower than avg
Panel avg: 127d · This submission: 242d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EBG Crown And Bridge, Temporary, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3770
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 - EBG Crown And Bridge, Temporary, Resin

All 92
Devices cleared under the same product code (EBG) and FDA review panel - the closest regulatory comparables to K142371.
Resin for Temporary Crown & Bridge
K180657 · Dentis Co., Ltd. · Dec 2018
TEMP BASIC, TEMP PREMIUM, TEMP PREMIUM FLEXIBLE, MULTISTRATUM FLEXIBLE, THERAPON, TRY-IN, BURNOUT, TRY-IN & BURNOUT
K180562 · Zirkonzahn GmbH · Jun 2018
TelioCAD Multi
K153753 · Ivoclar Vivadent, Inc. · Apr 2016
MSN-006
K141562 · GC America, Inc. · Sep 2014
STRUCTUR 3
K120779 · Voco GmbH · Jun 2012
PRO-V COAT
K103514 · Bisco, Inc. · May 2011