Cleared Traditional

K162323 - Tooth Shade Resin Material

K162323 is an FDA 510(k) clearance for Tooth Shade Resin Material, manufactured by Liaoning Upcera Co., Ltd.. The device is a Class 2 Dental device with product code EBF cleared through the Traditional 510(k) pathway after a 146-day FDA review.

K162323 · Liaoning Upcera Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2017
Decision
146d
Days
Class 2
Risk

K162323 is an FDA 510(k) clearance for the Tooth Shade Resin Material. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Liaoning Upcera Co., Ltd. (Benxi, CN). The FDA issued a Cleared decision on January 12, 2017 after a review of 146 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3690 - 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 - K162323

510(k) Number K162323 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 2016
Decision Date January 12, 2017
Days to Decision 146 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
19d slower than avg
Panel avg: 127d · This submission: 146d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBF Device Classification - Class 2, Special Controls

Product Code EBF Material, Tooth Shade, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3690
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 - EBF Material, Tooth Shade, Resin

All 646
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K162323.
REVEAL Bulk
K171147 · Bisco, Inc. · Aug 2017
Admira Fusion x-base
K170896 · Voco GmbH · Jun 2017
Renamel NANO +plus
K163480 · Cosmedent, Inc. · Feb 2017
CERAMAGE UP
K162261 · Shofu Dental Corporation · Jan 2017
Filtek One Bulk Fill Restorative
K163207 · 3M Company · Nov 2016
CAD/CAMouflage Milling Block
K162537 · Prismatik Dentalcraft, Inc. · Nov 2016