Cleared Traditional

C&B NFH Hybrid (K232559) - FDA 510(k) Clearance

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

K232559 · Arum Dentistry Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2024
Decision
385d
Days
Class 2
Risk

K232559 is an FDA 510(k) clearance for the C&B NFH Hybrid. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Arum Dentistry Co., Ltd. (Daejeon, KR). The FDA issued a Cleared decision on September 11, 2024 after a review of 385 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Arum Dentistry Co., Ltd. devices

Submission Details

510(k) Number K232559 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 2023
Decision Date September 11, 2024
Days to Decision 385 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
258d slower than avg
Panel avg: 127d · This submission: 385d
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 K232559.
Crown HT
K242277 · Sprintray, Inc. · Oct 2024
Any-Com
K241147 · Mediclus Co., Ltd. · Sep 2024
Signum composite flow
K240660 · Kulzer, LLC · Sep 2024
els extra low shrinkage® composite & els extra low shrinkage® flow
K240823 · Saremco Dental AG · Jun 2024
Temporis, Irix Plus
K231142 · Dws S.R.L. · Apr 2024
Light Cure Composite
K240112 · Sincera Technology (Changchun) Co., Ltd. · Mar 2024