Cleared Traditional

AH Plus Endodontic Sealer

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

About This 510(k) Submission

K243546 is an FDA 510(k) clearance for the AH Plus Endodontic Sealer, a Resin, Root Canal Filling (Class II — Special Controls, product code KIF), submitted by Dentsply Sirona, Inc. (York, US). The FDA issued a Cleared decision on February 13, 2025, 90 days after receiving the submission on November 15, 2024. This device falls under the Dental review panel. Regulated under 21 CFR 872.3820.

Submission Details

510(k) Number K243546 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code KIF — Resin, Root Canal Filling
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3820