Cleared Traditional

TopCEM Dual Cure Resin Cement (K233082) - FDA 510(k) Clearance

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

K233082 · Rizhao Huge Biomaterials Company, Ltd. · Dental device
Download Printable Device Report (PDF)
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Dec 2023
Decision
87d
Days
Class 2
Risk

K233082 is an FDA 510(k) clearance for the TopCEM Dual Cure Resin Cement. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Rizhao Huge Biomaterials Company, Ltd. (Rizhao, CN). The FDA issued a Cleared decision on December 22, 2023 after a review of 87 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3690 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Rizhao Huge Biomaterials Company, Ltd. devices

Submission Details

510(k) Number K233082 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2023
Decision Date December 22, 2023
Days to Decision 87 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 127d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EBF Material, Tooth Shade, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3690
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 Peers - EBF Material, Tooth Shade, Resin

All 291
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K233082.
Light Cure Composite
K240112 · Sincera Technology (Changchun) Co., Ltd. · Mar 2024
FORMA Composite (Shade A3D)
K240694 · Ultradent Products, Inc. · Mar 2024
Fusion Core DC Flo
K231263 · Prevest Denpro Limited · Jan 2024
saremco print BRIDGETEC
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VarseoSmile TriniQ
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TERA HARZ II
K233502 · Graphy, Inc. · Nov 2023