(90 days)
Not Found
No
The device description and performance studies focus on the material properties and sealing capabilities of an endodontic sealer, with no mention of AI or ML.
Yes
This device is a root canal sealer used in endodontic treatment to permanently obturate root canals, which is a therapeutic intervention.
No
The device is a permanent root canal sealer used for obturation, which is a treatment process, not a diagnostic one.
No
The device description clearly states it is a two-component paste-paste permanent root canal sealer based on epoxyamine resin, available in tubes or a syringe. This describes a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Permanent obturation of root canals of the secondary dentition in combination with root canal points." This describes a procedure performed on the patient's body (filling a root canal), not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description details a material used to seal a root canal, which is a physical intervention within the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting markers, or providing diagnostic information about a patient's health status.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
Permanent obturation of root canals of the secondary dentition in combination with root canal points.
Product codes (comma separated list FDA assigned to the subject device)
KIF
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Root Canal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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 Pyrogen Test (USP Rabbit Test) ●
Key Results: 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. The biological risk assessment concludes that the test results meet the requirements of the specified ISO 10993 standard series.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Radiopacity: Pass
Solubility: Pass
Setting Time: Pass
Film Thickness: Pass
Flow: Pass
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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.
1
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
2
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
3
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)
-
- 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
- Submitter Information: Dentsply Sirona 221 West Philadelphia Street Suite 60W York, PA 17404
Date Prepared: 15 November 2024
-
- 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 |
-
- Predicate Device:
| Table FS.1: Predicate device information | ||
|---|---|---|
| Primary Predicate Device | ||
| 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 | |||
| Comparison | Proposed device | ||
| AH Plus Endodontic Sealer | |||
| (K243546) | Predicate device | ||
| AH Plus Root Canal Sealer | |||
| (K960548) | Discussion | ||
| Manufacturer | Dentsply DeTrey GmbH | Dentsply DeTrey GmbH | Same |
| Product Code | KIF | KIF | Same |
| Site of | |||
| Application | 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 mixing | ||
| of Paste 1 and Paste 2 | |||
| Image: AH Plus in tubes |
· AH Plus Jet® Dual-barrel syringe
with mixing tip
Image: AH Plus Jet Dual-barrel syringe | · AH Plus® in tubes for manual mixing
of Paste A and Paste B
Image: AH Plus in tubes | The proposed AH Plus Endodontic
Sealer in the tubes are for manual
mixing and are similar to the
predicate with the exception of the
color layout of the tubes.
The proposed AH Plus Jet
Endodontic Sealer contains the
same sealer material (Paste 1 and
Paste 2) as the tubes but packaged
in a dual-barrel syringe with an
intraoral mixing tip.
The mixing tip attached to the
syringe mixes the sealer when
extruded whereas the tubes are
manually mixed on a mixing pad. |
| Mode of Action | The final product consists of two
components, the epoxy resin paste and
the amine paste, that are mixed prior to
insertion into the root canal. | The final product consists of two
components, the epoxy resin paste and the
amine paste, that are mixed prior to
insertion into the root canal. | Same |
| Table FS.2-Comparison of the proposed and predicate devices | | | |
| Item of
Comparison | Proposed device
AH Plus Endodontic Sealer
(K243546) | Predicate device
AH Plus Root Canal Sealer
(K960548) | Discussion |
| Biocompatibility | Meets ISO 10993-1:2018 requirements | Meets ISO 10993 requirements | The proposed device conforms to
the most recent FDA recognized
version of the standard. |
| Performance | Meets ISO 6876:2012 Dentistry-Root
Canal Sealing Materials | Meets ISO 6876:1996 Dentistry-Root Canal
Sealing Materials | Same ISO standard applied for
testing using the version recognized
at the time the testing was
performed. Performance results
according to ISO 6876are
acceptable. |
7
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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 | |
| 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 Pyrogen Test (USP Rabbit Test) ●
9
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.