Skip to content

AH Plus Endodontic Sealer

by Dentsply Sirona, Inc. 510(k)

Active United States

510(k) K243546

Overview

AH Plus Endodontic Sealer is a resin-based root canal filling device classified as a Class II medical device. It is substantially equivalent to a predicate device and has been cleared for marketing under the traditional 510(k) pathway. The device is intended for use in dental applications, specifically as a sealer for the final obturation of root canals in permanent teeth.

The sealer is supplied by Dentsply Sirona, Inc., located at 221 W. Philadelphia St., Suite 60w, York, PA 17401, United States. It is regulated under FDA product code KIF and regulation number 872.3820. The device is not described as sterile, single-use, or reusable in the provided data, and no MRI safety information is specified.

AI-generated from registry data, 23 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK243546 Date13 Feb 2025ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
KIF
Device Class
Class II
Regulation
21 CFR Part 872.3820
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Other devices from Dentsply Sirona Inc

See all devices from Dentsply Sirona Inc →

Questions

  • What is the AH Plus Endodontic Sealer used for?

    The AH Plus Endodontic Sealer is intended for use as a sealer in the final obturation of root canals in permanent teeth, based on its resin-based formulation designed for dental applications.

  • How is the AH Plus Endodontic Sealer supplied and by whom?

    The device is supplied by Dentsply Sirona, Inc., located at 221 W. Philadelphia St., Suite 60w, York, PA 17401, United States, as indicated in the manufacturer address details provided in the device data.

  • Is the AH Plus Endodontic Sealer described as sterile, single-use, or reusable in the provided data?

    The device data does not describe the AH Plus Endodontic Sealer as sterile, single-use, or reusable; no such specifications are included in the provided information.