Cleared Traditional

K232438 - Dental Glass Ceramics Blocks

K232438 is an FDA 510(k) clearance for Dental Glass Ceramics Blocks, manufactured by Aibodent Biotechnology Co., Ltd.. The device is a Class 2 Dental device with product code EIH cleared through the Traditional 510(k) pathway after a 109-day FDA review.

K232438 · Aibodent Biotechnology Co., Ltd. · Dental device
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Dec 2023
Decision
109d
Days
Class 2
Risk

K232438 is an FDA 510(k) clearance for the Dental Glass Ceramics Blocks. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by Aibodent Biotechnology Co., Ltd. (Changsha, CN). The FDA issued a Cleared decision on December 1, 2023 after a review of 109 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 Aibodent Biotechnology Co., Ltd. devices

FDA 510(k) Submission Details - K232438

510(k) Number K232438 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 2023
Decision Date December 01, 2023
Days to Decision 109 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
18d faster than avg
Panel avg: 127d · This submission: 109d
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

Guangzhou Junyi Information Technology Co., Ltd.
Shanfeng Jiang

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 K232438.
Dental Porcelain Powder
K232676 · Chengdu Besmile Medical Technology Co., Ltd. · Jan 2024
Zirconia Block
K233125 · Hangzhou Ivista Medical Devices Co., Ltd. · Jan 2024
Dental Glass Ceramics
K233016 · Shenzhen Yurucheng Dental Materials Co., Ltd. · Dec 2023
Gradual Dental Zirconia Blank
K231687 · Liaoning Upcera Co., Ltd. · Sep 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