Cleared Traditional

K142371 - Luminesse PMMA

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

K142371 · Talladium, Inc. · Dental device
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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

FDA 510(k) Submission Details - K142371

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
Combination Product No
PCCP Authorized No
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.

EBG Device Classification - Class 2, Special Controls

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 150
Devices cleared under the same product code (EBG) and FDA review panel - the closest regulatory comparables to K142371.
YAMAHACHI PMMA DISKS
K151764 · Yamahachi Dental Products USA, Inc. · Nov 2015
SuPro 100
K151144 · 3M Deutschland GmbH · Sep 2015
IDODENTINE DISC, IDODENTINE BLOCK
K150432 · Union Dental S.A. · Aug 2015
TIZIAN BLANK, TIZIAN ZIRCONIUM REINFORCED COMPOSITE BLANK, TIZIAN COLOR BLANK, TIZIAN BLANK OCCLUSAL, TIZIAN BLANK TRANS
K133268 · Schutz-Dental GmbH · Feb 2015
PMMA BLOCK
K141421 · Rizhao Huge Dental Industry Co., Ltd. · Feb 2015
MSN-006
K141562 · GC America, Inc. · Sep 2014