Cleared Traditional

K243546 - AH Plus Endodontic Sealer

K243546 is the FDA 510(k) clearance for AH Plus Endodontic Sealer by Dentsply Sirona, Inc.. It is a Class 2 Dental device (product code KIF) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K243546 · Dentsply Sirona, Inc. · Dental device
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Feb 2025
Decision
90d
Days
Class 2
Risk

K243546 is an FDA 510(k) clearance for the AH Plus Endodontic Sealer. Classified as Resin, Root Canal Filling (product code KIF), Class II - Special Controls.

Submitted by Dentsply Sirona, Inc. (York, US). The FDA issued a Cleared decision on February 13, 2025 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 Dentsply Sirona, Inc. devices

Submission Details

510(k) Number K243546 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 2024
Decision Date February 13, 2025
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 Peers - KIF Resin, Root Canal Filling

All 74
Devices cleared under the same product code (KIF) and FDA review panel - the closest regulatory comparables to K243546.
MTA vpt
K251390 · Voco GmbH · Jul 2025
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K250710 · Enpuno Co., Ltd. · Jun 2025
One-Fil Putty
K243353 · Mediclus Co., Ltd. · Mar 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
Injectable Root Canal Bioceramic Sealer (i-MTA SP)
K241977 · Longly Biotechnology (Wuhan) Co., Ltd. · Oct 2024