Endofill

K231387 · Lumendo AG · KIF · Jul 10, 2023 · Dental

Device Facts

• Record ID: K231387
• Device Name: Endofill
• Applicant: Lumendo AG
• Product Code: KIF · Dental
• Decision Date: Jul 10, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3820
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Endofill is a hydrophilic, radiopaque root canal filling material. It is supplied as a liquid, flowable material in single-use plastic syringes. During root canal treatment, a clinician injects the material into a cleaned and prepared root canal. The material is then converted into a solid, crosslinked, insoluble hydrogel polymer via photocuring. The cured material remains in the canal to provide a permanent seal (obturate). The device is intended for use by dental professionals in a clinical setting.

Clinical Evidence

Bench testing only. Performance evaluated per ISO 6876:2012, including flow, film thickness, solubility, disintegration, and radiopacity. Biocompatibility assessed per ISO 10993-1:2018 and ISO 7405:2018.

Technological Characteristics

Hydrophilic, radiopaque root canal filling resin. Composed of cross-linkable compound, solvent, radiopacifier, and initiator. Forms crosslinked, insoluble hydrogel polymer via photocuring. Provided in single-use plastic syringes in aluminum-laminate pouches. Complies with ISO 6876:2012, ISO 10993-1:2018, and ISO 7405:2018.

Indications for Use

Indicated for permanent obturation of root canals following root canal treatment in patients requiring endodontic therapy.

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

• Sonendo Filling Material 5C (K211995)
• EndoREZ Dual Cure (K071106)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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 | [phone] |
| Applicant Contact | Dr. Mark Bispinghoff |
| Applicant Contact Email | [e-mail] |
| 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.