(59 days)
Not Found
No
The description focuses on the material properties and physical function of the device, with no mention of AI or ML.
No.
The device is intended for permanent obturation (sealing) of root canals, which is a structural rather than a therapeutic function.
No
The device is a material for obturation (sealing) of root canals, which is a treatment procedure, not a diagnostic one.
No
The device description clearly states that Endofill is a "hydrophilic, radiopaque material" provided in "single-use plastic syringes." This indicates a physical material and delivery system, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "permanent obturation of root canals following root canal treatment." This is a therapeutic procedure performed directly on the patient's body to seal the root canal.
- Device Description: The device is a material injected into the root canal and cured. It directly contacts the tissue within the root canal.
- Lack of Diagnostic Purpose: There is no mention of the device being used to examine specimens derived from the human body to provide information for diagnostic purposes. IVDs are typically used to test blood, urine, tissue samples, etc., to detect diseases, conditions, or states of health.
Therefore, Endofill is a medical device used for a therapeutic purpose within the body, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Endofill is indicated for the permanent obturation of root canals following root canal treatment
Product codes (comma separated list FDA assigned to the subject device)
KIF
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
root canals
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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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
1
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)
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.