Cleared Traditional

K240304 - Injectable Root Canal Bioceramic Sealer...

K240304 is an FDA 510(k) clearance for Injectable Root Canal Bioceramic Sealer..., manufactured by Enpuno Biotechnology Co., Ltd.. The device is a Class 2 Dental device with product code KIF cleared through the Traditional 510(k) pathway after a 116-day FDA review.

K240304 · Enpuno Biotechnology Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2024
Decision
116d
Days
Class 2
Risk

K240304 is an FDA 510(k) clearance for the Injectable Root Canal Bioceramic Sealer (NR SP-0.5, NR SP-1, NR SP-2, NR SP-3.... Classified as Resin, Root Canal Filling (product code KIF), Class II - Special Controls.

Submitted by Enpuno Biotechnology Co., Ltd. (Changsha High-Tech Development Zone Chan, CN). The FDA issued a Cleared decision on May 28, 2024 after a review of 116 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 Enpuno Biotechnology Co., Ltd. devices

FDA 510(k) Submission Details - K240304

510(k) Number K240304 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 2024
Decision Date May 28, 2024
Days to Decision 116 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
11d faster than avg
Panel avg: 127d · This submission: 116d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KIF Device Classification - Class 2, Special Controls

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 83
Devices cleared under the same product code (KIF) and FDA review panel - the closest regulatory comparables to K240304.
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
Calx-O, Calcium Hydroxide Powder, Calahyd RC, CeraSeal B, MTA, Rootfyx, Sealmax R, Sealmax +
K240446 · Shiva Products · Jul 2024
Bioceramic Root Repair Material (C-Root BP)
K240365 · Beijing C-Root Dental Medical Devices Co., Ltd. · May 2024
One-Fil
K232182 · Mediclus Co., Ltd. · Jan 2024
CeraPutty
K232299 · Meta Biomed Co., Ltd. · Sep 2023