Cleared Traditional

K141724 - UPCERA DENTAL ZIRCONIA BLANK & DENTAL Z...

K141724 is an FDA 510(k) clearance for UPCERA DENTAL ZIRCONIA BLANK & DENTAL Z..., manufactured by Liaoning Upcera Co., Ltd.. The device is a Class 2 Dental device with product code EIH cleared through the Traditional 510(k) pathway after a 118-day FDA review.

K141724 · Liaoning Upcera Co., Ltd. · Dental device
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Optimized for regulatory review, auditing and printing
Oct 2014
Decision
118d
Days
Class 2
Risk

K141724 is an FDA 510(k) clearance for the UPCERA DENTAL ZIRCONIA BLANK & DENTAL ZIRCONIA PRE-SHADED BLANK. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by Liaoning Upcera Co., Ltd. (New Milford, US). The FDA issued a Cleared decision on October 22, 2014 after a review of 118 days - within the typical 510(k) review window.

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 Liaoning Upcera Co., Ltd. devices

FDA 510(k) Submission Details - K141724

510(k) Number K141724 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 2014
Decision Date October 22, 2014
Days to Decision 118 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
9d faster than avg
Panel avg: 127d · This submission: 118d
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 286
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