Endofill is a hydrophilic, radiopaque material intended for permanent obturation of the root canals following root canal treatment. It consists of a liquid, flowable material that is injected into the prepared and cleaned root canal and converted into a solid polymer by photocuring. The cured material remains within the root canal to obturate (seal) it.
Endofill is provided ready-to-use in single-use plastic syringes which are sealed inside aluminum-laminate pouches.
The Endofill material is the only part of the device that directly contacts the tissue. The syringe in which the material is provided comes in contact with Endofill material, so it contacts the tissue indirectly.

AI/ML Overview

The provided text describes the 510(k) premarket notification for Lumendo AG's "Endofill" device, a root canal filling resin. It outlines the device's intended use, technological characteristics, and comparison to predicate devices, along with the non-clinical testing performed. However, it does not contain information about acceptance criteria, the specific study conducted to prove the device met those criteria, or details regarding expert involvement, ground truth establishment, or sample sizes related to AI/human reader performance.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or information about a study proving the device meets these criteria, as the requested details are not present in the provided document.

The document primarily focuses on demonstrating substantial equivalence to predicate devices through non-clinical bench performance testing and compliance with recognized standards.

Here's what can be extracted from the document regarding the non-clinical testing:

Non-Clinical Test Summary & Conclusions (as reported in the document):

Acceptance Criteria & Reported Performance: The document states that Endofill complies with the performance requirements set out in ISO 6876:2012. The specific measured values for each criterion are not provided in this summary, but the general compliance serves as the "reported device performance" in relation to the standards' acceptance criteria.

Acceptance Criteria (from ISO 6876:2012)	Reported Device Performance
Flow (as per ISO 6876:2012)	Complies with ISO 6876:2012
Film thickness (as per ISO 6876:2012)	Complies with ISO 6876:2012
Solubility & Disintegration (as per ISO 6876:2012)	Complies with ISO 6876:2012
Radiopacity (as per ISO 6876:2012)	Complies with ISO 6876:2012
Biocompatibility (ISO 10993-1:2018 & ISO 7405:2018)	Complies with ISO 10993-1:2018 & ISO 7405:2018

Sample size used for the test set and data provenance: Not specified in the provided text for the non-clinical bench testing.
Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable, as this was non-clinical bench testing, not a human reader or AI performance study.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable, as this was non-clinical bench testing.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, not mentioned. The study described is non-clinical bench testing.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: No, this is a physical dental material, not an algorithm.
The type of ground truth used: For the non-clinical bench testing, the "ground truth" are the standardized test methods and limits defined in ISO 6876:2012 for the physical-chemical properties, and ISO 10993-1:2018 and ISO 7405:2018 for biocompatibility.
The sample size for the training set: Not applicable, as this is a physical device, not an AI/ML algorithm.
How the ground truth for the training set was established: Not applicable.

In summary, the document details a 510(k) submission for a medical device (root canal filling resin), demonstrating its substantial equivalence through mechanical and chemical property testing against international standards (ISO 6876:2012, ISO 10993-1:2018, ISO 7405:2018). It does not involve AI, human reader studies, or complex clinical study designs typically associated with software as a medical device (SaMD) or AI-enabled technologies.

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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. Underneath the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

July 10, 2023

Lumendo AG Mark Bispinghoff Coo Chemin du Closel 5 Renens, VD 1020 SWITZERLAND

Re: K231387

Trade/Device Name: Endofill Regulation Number: 21 CFR 872.3820 Regulation Name: Root Canal Filling Resin Regulatory Class: Class II Product Code: KIF Dated: May 12, 2023 Received: May 12, 2023

Dear Mark Bispinghoff:

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 (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 located 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.

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

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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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 mediation-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-regulatoryassistance/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 E. Adjodha, M.ChE. 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

Submission Number (if known)

K231387

Device Name

Endofill (1)

Indications for Use (Describe)

Endofill (1) is indicated for the permanent obturation of root canals following root canal treatment

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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510(k) #:	510(k) Summary
Prepared on:	2023-06-27
Contact Details
	21 CFR 807.92(a)(1)
Applicant Name	Lumendo AG
Applicant Address	Chemin du Closel 5 Renens VD 1020 Switzerland
Applicant Contact Telephone	+41445896802
Applicant Contact	Dr. Mark Bispinghoff
Applicant Contact Email	mark.bispinghoff@lumendo.ch
Device Name
	21 CFR 807.92(a)(2)
Device Trade Name	Endofill (1)
Common Name	Root canal filling resin
Classification Name	Resin, Root Canal Filling
Regulation Number	872.3820
Product Code	KIF
Legally Marketed Predicate Devices
	21 CFR 807.92(a)(3)
Predicate #	Predicate Trade Name (Primary Predicate is listed first)
K211995	Sonendo Filling Material 5C
	KIF
K071106	EndoREZ Dual Cure
	KIF
Device Description Summary
	21 CFR 807.92(a)(4)
Endofill is a hydrophilic, radiopaque material intended for permanent obturation of the root canals following root canal treatment. It consists of a liquid, flowable material that is injected into the prepared and cleaned root canal and converted into a solid polymer by photocuring. The cured material remains within the root canal to obturate (seal) it.
Endofill is provided ready-to-use in single-use plastic syringes which are sealed inside aluminum-laminate pouches.
The Endofill material is the only part of the device that directly contacts the tissue. The syringe in which the material is provided comes in contact with Endofill material, so it contacts the tissue indirectly.
Intended Use/Indications for Use
	21 CFR 807.92(a)(5)
Endofill is indicated for the permanent obturation of root canals following root canal treatment
Indications for Use Comparison
	21 CFR 807.92(a)(5)
Endofill and the primary predicate device share an identical Indications for Use statement indicating the products are used for permanent obturation of the root canal following root canal treatment. The additional predicate device's Indications for Use statement lists specific modos of application and includes a statement that is may be used with all conventional endodontic obturation techniques

lists specific modes of application and includes a statement that is may be used with all conventional endodontic obturation techniques.

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Because the additional predicate may be used with all conventional endodontic obturation techniques, it shares the same intended use with Endofill and the primary predicate device (permanent obturation of the root canal treatment). Therefore, although the Indications for Use language differs between Endofill and the additional predicate device, these differences are not critical to the intended use of the device and do not affectiveness of the device when used as labeled.

Technological Comparison

21 CFR 807.92(a)(6)

Endofill has the same technological characteristics when compared to the primary and additional predicated to type of use, target users, material characteristics, principle of operation, treatment site, sterility, delivery form, packaging, and material compatibility.

Minor differences in the basic chemical composition, curing mechanism, and material properties tested were determined not to raise different questions of safety or effectiveness. The subject and the primary predicate device both form a crosslinked, insoluble hydrogel polymer upon curing and are composed of a cross-linkable compound, a solvent, a radiopacifier, and an initiator.

Endofill complies with the performance requirements set out in ISO68762012 and the biocompatibility requirements of ISO 10993-1:2018 and ISO7405:2018. Therefore, despite some differences in the basic chemical composition, performance, and safety (biocompatibility), test results support that the subject device is substantially equivalent to the predicate device.

Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)

Non-clinical bench performance testing was conducted to provide evidence that the physical-chemical properties of Endofill are substantially equivalent to the predicate devices and to support safety and performance of the device for its intended use.

The FDA-recognized consensus standard 4-199 (ISO 6876:2012) specifies the requirements and test methods for root canal (endodontic) sealing materials. Accordingly, flow, film thickness, solubility & disintegration, and radiopacity have been measured.

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.