AH Plus Endodontic Sealer

K243546 · Dentsply Sirona, Inc. · KIF · Feb 13, 2025 · Dental

Device Facts

• Record ID: K243546
• Device Name: AH Plus Endodontic Sealer
• Applicant: Dentsply Sirona, Inc.
• Product Code: KIF · Dental
• Decision Date: Feb 13, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3820
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

AH Plus Endodontic Sealer is a two-component epoxyamine resin paste used for permanent root canal obturation. It is supplied in two formats: tubes for manual mixing or a dual-barrel syringe with a disposable mixing tip for intraoral application. The device is used by dental professionals during endodontic procedures to seal prepared root canals. The two components (epoxy resin paste and amine paste) are mixed prior to insertion, where the material adapts to canal walls to provide a permanent seal and radiopacity. The device does not stain teeth. It functions as a restorative material to maintain tooth integrity.

Clinical Evidence

No clinical data included. Substantial equivalence supported by non-clinical bench testing and biocompatibility evaluation. Bench testing confirmed compliance with ISO 6876:2012 for radiopacity, solubility, setting time, film thickness, and flow. Biocompatibility testing conducted per ISO 10993 series (cytotoxicity, sensitization, irritation, genotoxicity, local effects) and USP <151>.

Technological Characteristics

Two-component epoxyamine resin paste. Delivery systems: manual mix tubes or dual-barrel syringe with intraoral mixing tip. Radiopaque. Biocompatibility per ISO 10993:2018 and ISO 7405:2018. Performance testing per ISO 6876:2012. Non-sterile. 2-year shelf life.

Indications for Use

Indicated for permanent obturation of root canals of teeth of the secondary dentition in combination with root canal points.

Regulatory Classification

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.

Predicate Devices

• AH Plus Root Canal Sealer (K960548)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

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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: [e-mail]

Date Prepared: 15 November 2024

- 2. 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 |

- 3. Predicate Device:

| <b>Table FS.1: Predicate device information</b> | | |
|-------------------------------------------------|---------|----------------|
| Primary Predicate Device<br>Name | 510(k) | Company Name |
| AH Plus Root Canal Sealer | K960548 | Dentsply Intl. |

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## 4. Description of Device:

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.

#### 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 of<br>Comparison | Proposed device<br>AH Plus Endodontic Sealer<br>(K243546) | Predicate device<br>AH Plus Root Canal Sealer<br>(K960548) | Discussion |
| Manufacturer | Dentsply DeTrey GmbH | Dentsply DeTrey GmbH | Same |
| Product Code | KIF | KIF | Same |
| Site of<br>Application | Root Canal | Root Canal | Same |
| Sterile | Non-sterile | Non-sterile | Same |
| Shelf-Life | 2 years | 2 years | Same |
| Packaging /<br>Delivery System | · AH Plus® in tubes for manual mixing<br>of Paste 1 and Paste 2<br>Image: AH Plus in tubes<br><br>· AH Plus Jet® Dual-barrel syringe<br>with mixing tip<br>Image: AH Plus Jet Dual-barrel syringe | · AH Plus® in tubes for manual mixing<br>of Paste A and Paste B<br>Image: AH Plus in tubes | The proposed AH Plus Endodontic<br>Sealer in the tubes are for manual<br>mixing and are similar to the<br>predicate with the exception of the<br>color layout of the tubes.<br><br>The proposed AH Plus Jet<br>Endodontic Sealer contains the<br>same sealer material (Paste 1 and<br>Paste 2) as the tubes but packaged<br>in a dual-barrel syringe with an<br>intraoral mixing tip.<br><br>The mixing tip attached to the<br>syringe mixes the sealer when<br>extruded whereas the tubes are<br>manually mixed on a mixing pad. |
| Mode of Action | The final product consists of two<br>components, the epoxy resin paste and<br>the amine paste, that are mixed prior to<br>insertion into the root canal. | The final product consists of two<br>components, the epoxy resin paste and the<br>amine paste, that are mixed prior to<br>insertion into the root canal. | Same |
| Table FS.2-Comparison of the proposed and predicate devices | | | |
| Item of<br>Comparison | Proposed device<br>AH Plus Endodontic Sealer<br>(K243546) | Predicate device<br>AH Plus Root Canal Sealer<br>(K960548) | Discussion |
| Biocompatibility | Meets ISO 10993-1:2018 requirements | Meets ISO 10993 requirements | The proposed device conforms to<br>the most recent FDA recognized<br>version of the standard. |
| Performance | Meets ISO 6876:2012 Dentistry-Root<br>Canal Sealing Materials | Meets ISO 6876:1996 Dentistry-Root Canal<br>Sealing Materials | Same ISO standard applied for<br>testing using the version recognized<br>at the time the testing was<br>performed. Performance results<br>according to ISO 6876are<br>acceptable. |

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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-Root<br>Canal 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.