Cleared Traditional

K250710 - Injectable Root Canal Bioceramic Sealer...

K250710 is an FDA 510(k) clearance for Injectable Root Canal Bioceramic Sealer..., manufactured by Enpuno Co., Ltd.. The device is a Class 2 Dental device with product code KIF cleared through the Traditional 510(k) pathway after a 93-day FDA review.

K250710 · Enpuno Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2025
Decision
93d
Days
Class 2
Risk

K250710 is an FDA 510(k) clearance for the Injectable Root Canal Bioceramic Sealer (nRoot SP). Classified as Resin, Root Canal Filling (product code KIF), Class II - Special Controls.

Submitted by Enpuno Co., Ltd. (Changsha, CN). The FDA issued a Cleared decision on June 11, 2025 after a review of 93 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 Co., Ltd. devices

FDA 510(k) Submission Details - K250710

510(k) Number K250710 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 2025
Decision Date June 11, 2025
Days to Decision 93 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
34d faster than avg
Panel avg: 127d · This submission: 93d
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 K250710.
Well-Root PT
K252285 · Vericom Co., Ltd. · Sep 2025
One-Fil Putty Injectable
K251884 · Mediclus Co., Ltd. · Aug 2025
MTA vpt
K251390 · Voco GmbH · Jul 2025
One-Fil Putty
K243353 · Mediclus Co., Ltd. · Mar 2025
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