Cleared Traditional

K223477 - PMMA Blocks for Dental Use (FDA 510(k) Clearance)

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

K223477 · Aidite (Qinhuangdao) Technology Co., Ltd. · Dental device
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Feb 2023
Decision
90d
Days
Class 2
Risk

K223477 is an FDA 510(k) clearance for the PMMA Blocks for Dental Use. Classified as Crown And Bridge, Temporary, Resin (product code EBG), Class II - Special Controls.

Submitted by Aidite (Qinhuangdao) Technology Co., Ltd. (Qinhuangdao, CN). The FDA issued a Cleared decision on February 16, 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 872.3770 - 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 Aidite (Qinhuangdao) Technology Co., Ltd. devices

Submission Details

510(k) Number K223477 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 2022
Decision Date February 16, 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 EBG Crown And Bridge, Temporary, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3770
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

Shanghai Truthful Information Technology Co., Ltd.
Boyle 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 - EBG Crown And Bridge, Temporary, Resin

All 188
Devices cleared under the same product code (EBG) and FDA review panel - the closest regulatory comparables to K223477.
Dura-Arch
K261261 · Hangzhou SHINING3D Dental Technology Co., Ltd. · Apr 2026
“FLNT Base” and “FLNT Temp”
K253380 · Liaoning Upcera Co., Ltd. · Mar 2026
TempFIT Temporary Crown and Bridge Resin
K251271 · Rizhao Huge Biomaterials Company, Ltd. · Jun 2025
DentaTOOTH
K243370 · Asiga Pty, Ltd. · May 2025
Evoblock, Perléon
K243621 · Evoden Ind?stria Com?rcio Importa??o E Exporta??o · Apr 2025
TEMP MASTER, PMMA-based dental resin
K243951 · Taiwan Dental Materials Co., Ltd. · Feb 2025