Cleared Traditional

K223194 - Glass Ceramic

K223194 is an FDA 510(k) clearance for Glass Ceramic, manufactured by Shenzhen Xiangtong Co., Ltd.. The device is a Class 2 Dental device with product code EIH cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K223194 · Shenzhen Xiangtong Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2023
Decision
120d
Days
Class 2
Risk

K223194 is an FDA 510(k) clearance for the Glass Ceramic. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by Shenzhen Xiangtong Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on February 10, 2023 after a review of 120 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 Shenzhen Xiangtong Co., Ltd. devices

FDA 510(k) Submission Details - K223194

510(k) Number K223194 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 13, 2022
Decision Date February 10, 2023
Days to Decision 120 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
7d faster than avg
Panel avg: 127d · This submission: 120d
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

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 285
Devices cleared under the same product code (EIH) and FDA review panel - the closest regulatory comparables to K223194.
XT Stain/Glaze
K223192 · Shenzhen Xiangtong Co., Ltd. · Mar 2023
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Glass Ceramics
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ICE Ceramics, ICE Stains, Fresco
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Dental Zirconia Ceramic
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K222520 · Yilink (Tianjin) Biotechnology Co., Ltd. · Nov 2022