AH Plus Endodontic Sealer is a two-component paste-paste permanent root canal sealer based on epoxyamine resin. It is available in two delivery forms: AH Plus Endodontic Sealer in tubes, for an easy manual mix, or as AH Plus Jet Endodontic Sealer double-barrel syringe with a disposable mixing tip for intraoral use, offering a more precise, convenient, and faster procedure. It functions as part of the endodontic treatment, allowing for restoration of tooth integrity. It adapts closely to the walls of the prepared root canal and presents permanent sealing ability and radiopacity. AH Plus Endodontic Sealer does not stain teeth.

AI/ML Overview

This document is a 510(k) summary for the AH Plus Endodontic Sealer. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving device performance against specific acceptance criteria in the context of an AI-powered diagnostic device.

Therefore, many of the requested categories for AI/digital health devices are not directly applicable or are not explicitly detailed in this type of submission for a traditional medical device like an endodontic sealer.

However, I can extract the information related to performance testing as described for this device, specifically those aspects that function as "acceptance criteria" for the device's physical properties.

Acceptance Criteria and Study for AH Plus Endodontic Sealer (K243546)

1. Table of Acceptance Criteria and Reported Device Performance

Test Performed	Acceptance Criteria (Standard)	Reported Device Performance
Radiopacity	ISO 6876:2012 Dentistry-Root Canal Sealing Materials	Pass
Solubility	ISO 6876:2012 Dentistry-Root Canal Sealing Materials	Pass
Setting Time	ISO 6876:2012 Dentistry-Root Canal Sealing Materials	Pass
Film Thickness	ISO 6876:2012 Dentistry-Root Canal Sealing Materials	Pass
Flow	ISO 6876:2012 Dentistry-Root Canal Sealing Materials	Pass

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

This information is not provided in the document. The document describes non-clinical bench testing, not a clinical study involving patients or data provenance in that sense.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This is not applicable as the ground truth for the performance tests (radiopacity, solubility, etc.) is established by the physical and chemical properties measured against the ISO standard, not by expert interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable. The "test set" here refers to samples of the device material undergoing physical and chemical tests, not diagnostic cases requiring adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable. This is a submission for an endodontic sealer, which is a physical material, not an AI-powered diagnostic device. No human reader or AI assistance is involved.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable. This device is not an algorithm or software.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the performance tests is the specified limits and methodologies defined within the ISO 6876:2012 standard for dentistry-root canal sealing materials. For biocompatibility, the ground truth is adherence to the specified ISO 10993 series and USP standards.

8. The sample size for the training set

This is not applicable. This is a physical medical device, not an AI model. There is no concept of a "training set."

9. How the ground truth for the training set was established

This is not applicable.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION".

February 13, 2025

Dentsply Sirona Inc. Rebecca Sporer Principle Regulatory Affairs Specialist 221 W Philadelphia Street. Suite 60W York, Pennsylvania 17401

Re: K243546

Trade/Device Name: AH Plus Endodontic Sealer Regulation Number: 21 CFR 872.3820 Regulation Name: Root Canal Filling Resin Regulatory Class: Class II Product Code: KIF Dated: November 15, 2024 Received: November 15, 2024

Dear Rebecca Sporer:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801; medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatory

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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

MICHAEL E. ADJODHA -S

Michael Adjodha, MChE, RAC, CQIA Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.

Submission Number (if known)

K243546

Device Name

AH Plus Endodontic Sealer

Indications for Use (Describe)

Permanent obturation of root canals of the secondary dentition in combination with root canal points.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Dentsply Sirona 221 West Philadelphia Street Suite 60W York, PA 17401

Image /page/4/Picture/1 description: The image contains the logo for Dentsply Sirona. The logo consists of a blue abstract shape on the left, resembling a stylized letter 'S' or a curved ribbon. To the right of the shape are the words "Dentsply" and "Sirona" stacked vertically, also in blue. The overall design is clean and modern, representing the company's brand identity.

510(k) SUMMARY for AH Plus Endodontic Sealer (K243546)

1. Submitter Information: Dentsply Sirona 221 West Philadelphia Street Suite 60W York, PA 17404
  Contact Person: Rebecca Sporer Telephone Number: 717-849-4793 Email address: Rebecca.sporer@dentsplysirona.com

Date Prepared: 15 November 2024

1. Device Name:

Proprietary Name:	AH Plus Endodontics Sealer
Common Name:	Root canal filling resin
Classification Name:	Resin, Root Canal Filling
CFR Number:	872.3820
Device Class:	2
Product Code:	KIF

1. Predicate Device:

Table FS.1: Predicate device information
Primary Predicate DeviceName	510(k)	Company Name
AH Plus Root Canal Sealer	K960548	Dentsply Intl.

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4. Description of Device:

5. Indications for Use:

Permanent obturation of root canals of teeth of the secondary dentition in combination with root canal points.

6. Comparison of Technological Characteristics:

The proposed AH Plus Endodontic Sealer has a similar intended use and the same Indications for Use as compared to the predicate, AH Plus Root Canal Sealer (K960548). The proposed AH Plus Endodontic Sealer and the predicate, AH Plus Root Canal Sealer (K960548), are similar in design, principles of operation and composition. The proposed and predicate devices are both epoxide and amine pastes. The composition differences are due to market availability of the raw materials and added modifiers for added physical paste stability. The proposed device is offered in two delivery systems: tubes for manual mixing on a mixing pad and dual-barrel syringe with mixing tips that mixes the pastes as extruded from the syringe. Table FS.2 compares the technological characteristics of the proposed and predicate devices.

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Table FS.2-Comparison of the proposed and predicate devices
Item ofComparison	Proposed deviceAH Plus Endodontic Sealer(K243546)	Predicate deviceAH Plus Root Canal Sealer(K960548)	Discussion
Manufacturer	Dentsply DeTrey GmbH	Dentsply DeTrey GmbH	Same
Product Code	KIF	KIF	Same
Site ofApplication	Root Canal	Root Canal	Same
Sterile	Non-sterile	Non-sterile	Same
Shelf-Life	2 years	2 years	Same
Packaging /Delivery System	· AH Plus® in tubes for manual mixingof Paste 1 and Paste 2Image: AH Plus in tubes· AH Plus Jet® Dual-barrel syringewith mixing tipImage: AH Plus Jet Dual-barrel syringe	· AH Plus® in tubes for manual mixingof Paste A and Paste BImage: AH Plus in tubes	The proposed AH Plus EndodonticSealer in the tubes are for manualmixing and are similar to thepredicate with the exception of thecolor layout of the tubes.The proposed AH Plus JetEndodontic Sealer contains thesame sealer material (Paste 1 andPaste 2) as the tubes but packagedin a dual-barrel syringe with anintraoral mixing tip.The mixing tip attached to thesyringe mixes the sealer whenextruded whereas the tubes aremanually mixed on a mixing pad.
Mode of Action	The final product consists of twocomponents, the epoxy resin paste andthe amine paste, that are mixed prior toinsertion into the root canal.	The final product consists of twocomponents, the epoxy resin paste and theamine paste, that are mixed prior toinsertion into the root canal.	Same
Table FS.2-Comparison of the proposed and predicate devices
Item ofComparison	Proposed deviceAH Plus Endodontic Sealer(K243546)	Predicate deviceAH Plus Root Canal Sealer(K960548)	Discussion
Biocompatibility	Meets ISO 10993-1:2018 requirements	Meets ISO 10993 requirements	The proposed device conforms tothe most recent FDA recognizedversion of the standard.
Performance	Meets ISO 6876:2012 Dentistry-RootCanal Sealing Materials	Meets ISO 6876:1996 Dentistry-Root CanalSealing Materials	Same ISO standard applied fortesting using the version recognizedat the time the testing wasperformed. Performance resultsaccording to ISO 6876areacceptable.

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7. Non-Clinical Performance Data

Performance Testing:

The proposed AH Plus Endodontic Sealer was tested and conforms to:

ISO 6876:2012 Dentistry-Root canal sealing materials
The performance results of the proposed AH Plus Endodontic Sealer satisfactorily met the requirements of the non-clinical bench testing conducted to support substantial equivalence. Table FS.3 summarizes the bench testing conducted on the proposed device according to ISO 6872:2012.

Table FS.3- Performance Bench Testing according to ISO 6876:2012
Test Performed	Test method / Applicable Standard	Results
Radiopacity	ISO 6876:2012 Dentistry-RootCanal Sealing Materials	Pass
Solubility		Pass
Setting Time		Pass
Film Thickness		Pass
Flow		Pass

Biocompatibility Testing:

A biological risk assessment was conducted on the proposed AH Plus Endodontic Sealer. Review of available information on raw materials, manufacturing processes, chemical characterization tests concludes that the test results meet the requirements of the following ISO 10993 standard series.

The following tests were conducted:

. ISO 7405: 2018 Dentistry-Evaluation of biocompatibility of medical device used in dentistry
. ISO 10993-1:2018 Biological evaluation of medical devices-Part 1: Evaluation and testing within a risk management process
ISO 10993-18:2020 Biological evaluation of medical devices Part 18: Chemical ● characterization of medical device materials within a risk management process
ISO 10993-5: 2009 Biological evaluation of medical devices Part 5: Tests for in vitro . cytotoxicity
ISO 10993-10: 2021 Biological evaluation of medical devices Part 10: Tests for skin . sensitization
ISO 10993-23: 2021 Biological evaluation of medical devices Part 23: Tests for irritation ●
ISO 10993-3: 2014 Biological evaluation of medical devices Part 3: Tests for genotoxicity, ● carcinogenicity and reproductive toxicity
ISO 10993-6: 2016 Biological evaluation of medical devices Part 6: Tests for local effects after ● implantation
USP <151> Pyrogen Test (USP Rabbit Test) ●

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Conclusion:

Minor differences in the technological characteristics between the proposed and predicate (K960548) devices were evaluated through appropriate performance bench testing and biocompatibility testing which demonstrated that the proposed device, when compared to the predicate device (K960548), does not raise new questions regarding safety and effectiveness. The nonclinical testing data supports the conclusion that the proposed device performs as well as the predicate device (K960548).

8. Clinical Performance Data

No data from human clinical studies has been included to support the substantial equivalence of the proposed AH Plus Endodontic Sealer.

9. Conclusion Regarding Substantial Equivalence

The proposed AH Plus Endodontic Sealer is a root canal sealer which is intended for permanent sealing of root canals following established endodontic procedures. The proposed AH Plus Endodontic Sealer has a similar intended use, incorporates similar fundamental technologies, and has the same Indications for Use as the predicate AH Plus Root Canal Sealer (K960548). Test data is included in this premarket notification to verify the safety and performance requirements of the proposed AH Plus Endodontic Sealer and the results support a conclusion of substantial equivalence.

Regulation Number and Section

§ 872.3820 Root canal filling resin.

(a)
Identification. A root canal filling resin is a device composed of material, such as methylmethacrylate, intended for use during endodontic therapy to fill the root canal of a tooth.(b)
Classification. (1) Class II if chloroform is not used as an ingredient in the device.(2) Class III if chloroform is used as an ingredient in the device.
(c)
Date PMA or notice of completion of a PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before December 26, 1996 for any root canal filling resin described in paragraph (b)(2) of this section that was in commercial distribution before May 28, 1976, or that has, on or before December 26, 1996 been found to be substantially equivalent to a root canal filling resin described in paragraph (b)(2) of this section that was in commercial distribution before May 28, 1976. Any other root canal filling resin shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.