Cleared Traditional

K141727 - DENTAL LITHIUM DISILICATE GLASS CERAMIC...

K141727 is an FDA 510(k) clearance for DENTAL LITHIUM DISILICATE GLASS CERAMIC..., 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 175-day FDA review.

K141727 · Liaoning Upcera Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2014
Decision
175d
Days
Class 2
Risk

K141727 is an FDA 510(k) clearance for the DENTAL LITHIUM DISILICATE GLASS CERAMIC BLOCK (UP. PRESS SERIES AND UP. CAD S.... 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 December 18, 2014 after a review of 175 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 Liaoning Upcera Co., Ltd. devices

FDA 510(k) Submission Details - K141727

510(k) Number K141727 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 2014
Decision Date December 18, 2014
Days to Decision 175 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
48d slower than avg
Panel avg: 127d · This submission: 175d
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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