Cleared Traditional

Bioceramic Root Canal Sealer and Repair Materials (i-MTA BP) (K242934) - FDA 510(k) Clearance

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

K242934 · Longly Biotechnology (Wuhan) Co., Ltd. · Dental device
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Optimized for regulatory review, auditing and printing
Dec 2024
Decision
78d
Days
Class 2
Risk

K242934 is an FDA 510(k) clearance for the Bioceramic Root Canal Sealer and Repair Materials (i-MTA BP). Classified as Resin, Root Canal Filling (product code KIF), Class II - Special Controls.

Submitted by Longly Biotechnology (Wuhan) Co., Ltd. (Wuhan, CN). The FDA issued a Cleared decision on December 12, 2024 after a review of 78 days - a notably fast clearance cycle.

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: 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 Longly Biotechnology (Wuhan) Co., Ltd. devices

Submission Details

510(k) Number K242934 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 2024
Decision Date December 12, 2024
Days to Decision 78 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
49d faster than avg
Panel avg: 127d · This submission: 78d
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 Consultant

Beijing Xinranyicheng Medicine & Technology Co., Ltd.
Shirely Kong

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 - KIF Resin, Root Canal Filling

All 58
Devices cleared under the same product code (KIF) and FDA review panel - the closest regulatory comparables to K242934.
Injectable Root Canal Bioceramic Sealer (nRoot SP)
K250710 · Enpuno Co., Ltd. · Jun 2025
One-Fil Putty
K243353 · Mediclus Co., Ltd. · Mar 2025
AH Plus Endodontic Sealer
K243546 · Dentsply Sirona, Inc. · Feb 2025
VioSeal
K242702 · Spident Co., Ltd. · Nov 2024
Injectable Root Canal Bioceramic Sealer (i-MTA SP)
K241977 · Longly Biotechnology (Wuhan) Co., Ltd. · Oct 2024
Vista BC Putty
K241457 · Inter-Med, Inc. · Aug 2024