Cleared Traditional

Injectable Root Canal Bioceramic Sealer (i-MTA SP) (K241977) - FDA 510(k) Clearance

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

K241977 · Longly Biotechnology (Wuhan) Co., Ltd. · Dental device
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Oct 2024
Decision
90d
Days
Class 2
Risk

K241977 is an FDA 510(k) clearance for the Injectable Root Canal Bioceramic Sealer (i-MTA SP). 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 October 3, 2024 after a review of 90 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 Longly Biotechnology (Wuhan) Co., Ltd. devices

Submission Details

510(k) Number K241977 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 2024
Decision Date October 03, 2024
Days to Decision 90 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
37d faster than avg
Panel avg: 127d · This submission: 90d
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

Wuhan Tacro Technology Co., Ltd.
Alice Wu

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 K241977.
AH Plus Endodontic Sealer
K243546 · Dentsply Sirona, Inc. · Feb 2025
Bioceramic Root Canal Sealer and Repair Materials (i-MTA BP)
K242934 · Longly Biotechnology (Wuhan) Co., Ltd. · Dec 2024
VioSeal
K242702 · Spident Co., Ltd. · Nov 2024
Vista BC Putty
K241457 · Inter-Med, Inc. · Aug 2024
Calx-O, Calcium Hydroxide Powder, Calahyd RC, CeraSeal B, MTA, Rootfyx, Sealmax R, Sealmax +
K240446 · Shiva Products · Jul 2024
Injectable Root Canal Bioceramic Sealer (NR SP-0.5, NR SP-1, NR SP-2, NR SP-3, NR SP-5)
K240304 · Enpuno Biotechnology Co., Ltd. · May 2024