Cleared Traditional

K140848 - LUMINESSE PORCELAIN SYSTEM

K140848 is an FDA 510(k) clearance for LUMINESSE PORCELAIN SYSTEM, manufactured by Talladium, Inc.. The device is a Class 2 Dental device with product code EIH cleared through the Traditional 510(k) pathway after a 258-day FDA review.

K140848 · Talladium, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2014
Decision
258d
Days
Class 2
Risk

K140848 is an FDA 510(k) clearance for the LUMINESSE PORCELAIN SYSTEM. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by Talladium, Inc. (Valencia, US). The FDA issued a Cleared decision on December 17, 2014 after a review of 258 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6660 - 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 - K140848

510(k) Number K140848 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 2014
Decision Date December 17, 2014
Days to Decision 258 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
131d slower than avg
Panel avg: 127d · This submission: 258d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EIH Device Classification - Class 2, Special Controls

Product Code EIH Powder, Porcelain
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.6660
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 - EIH Powder, Porcelain

All 400
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