Cleared Traditional

K231687 - Gradual Dental Zirconia Blank (FDA 510(k) Clearance)

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K231687 · Liaoning Upcera Co., Ltd. · Dental device
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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

Submission Details

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.

Device Classification

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 478
Devices cleared under the same product code (EIH) and FDA review panel - the closest regulatory comparables to K231687.
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