Cleared Traditional

K181816 - Ceramic Denture Zirconia Ceramics Block

K181816 is the FDA 510(k) clearance for Ceramic Denture Zirconia Ceramics Block by Qinhuangdao Silide Ceramic Technology Co., Ltd.. It is a Class 2 Dental device (product code EIH) cleared through the Traditional 510(k) pathway after a 143-day FDA review.

K181816 · Qinhuangdao Silide Ceramic Technology Co., Ltd. · Dental device
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Nov 2018
Decision
143d
Days
Class 2
Risk

K181816 is an FDA 510(k) clearance for the Ceramic Denture Zirconia Ceramics Block. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by Qinhuangdao Silide Ceramic Technology Co., Ltd. (Qinhuangdao, CN). The FDA issued a Cleared decision on November 29, 2018 after a review of 143 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 Qinhuangdao Silide Ceramic Technology Co., Ltd. devices

Submission Details

510(k) Number K181816 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 2018
Decision Date November 29, 2018
Days to Decision 143 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
16d slower than avg
Panel avg: 127d · This submission: 143d
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

Beijing Believe-Med Technology Service Co., Ltd.
Ray Wang

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 260
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