Cleared Traditional

K232559 - C&B NFH Hybrid

K232559 is an FDA 510(k) clearance for C&B NFH Hybrid, manufactured by Arum Dentistry Co., Ltd.. The device is a Class 2 Dental device with product code EBF cleared through the Traditional 510(k) pathway after a 385-day FDA review.

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

FDA 510(k) Submission Details - K232559

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.

EBF Device Classification - Class 2, Special Controls

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 643
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K232559.
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