Cleared Traditional

K240365 - Bioceramic Root Repair Material (C-Root BP) (FDA 510(k) Clearance)

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

K240365 · Beijing C-Root Dental Medical Devices Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2024
Decision
94d
Days
Class 2
Risk

K240365 is an FDA 510(k) clearance for the Bioceramic Root Repair Material (C-Root BP). Classified as Resin, Root Canal Filling (product code KIF), Class II - Special Controls.

Submitted by Beijing C-Root Dental Medical Devices Co., Ltd. (Beijing, CN). The FDA issued a Cleared decision on May 10, 2024 after a review of 94 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3820 - 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 Beijing C-Root Dental Medical Devices Co., Ltd. devices

Submission Details

510(k) Number K240365 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 2024
Decision Date May 10, 2024
Days to Decision 94 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
33d faster than avg
Panel avg: 127d · This submission: 94d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KIF Resin, Root Canal Filling
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3820
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 - KIF Resin, Root Canal Filling

All 142
Devices cleared under the same product code (KIF) and FDA review panel - the closest regulatory comparables to K240365.
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