Cleared Traditional

K231687 - Gradual Dental Zirconia Blank

K231687 is an FDA 510(k) clearance for Gradual Dental Zirconia Blank, 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 90-day FDA review.

K231687 · Liaoning Upcera Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2023
Decision
90d
Days
Class 2
Risk

K231687 is an FDA 510(k) clearance for the Gradual Dental Zirconia Blank. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by Liaoning Upcera Co., Ltd. (Benxi, CN). The FDA issued a Cleared decision on September 7, 2023 after a review of 90 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 - K231687

510(k) Number K231687 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 2023
Decision Date September 07, 2023
Days to Decision 90 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
37d faster than avg
Panel avg: 127d · This submission: 90d
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 Consultant

Manton Business and Technology Services
Charles Shen

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - EIH Powder, Porcelain

All 285
Devices cleared under the same product code (EIH) and FDA review panel - the closest regulatory comparables to K231687.
Zirconia Block
K233125 · Hangzhou Ivista Medical Devices Co., Ltd. · Jan 2024
Dental Glass Ceramics
K233016 · Shenzhen Yurucheng Dental Materials Co., Ltd. · Dec 2023
Dental Glass Ceramics Blocks
K232438 · Aibodent Biotechnology Co., Ltd. · Dec 2023
Dental Lithium Disilicate Glass-Ceramic
K230487 · Fuzhou Rick Brown Biomaterials Co., Ltd. · Jul 2023
Easy On Universal Glaze & Stain
K231264 · Doctus Global · Jun 2023
Perfit CL
K223029 · Vatech Mcis Co., Ltd. · Jun 2023