(49 days)
This device is intended to be used in endodontic therapy as an improved method for applying Zinc Oxide-Eugenol sealing cement directly to the inside surface of a prepared root canal to coat and seal the canal walls prior to the introduction of gutta percha (or other restorative and filling materials).
The MPL Technologies Inc. Max-i-Probe Endodontic Sealer Delivery System is intended to be used in endodonic therapy by dental care professional in a clinical setting to apply Zinc Oxide-Eugenol sealing cement to the inside sufface of a prepared root canal prior to the introduction of gutta percha (or other restorative and filling materials).
The Max-i-Probe Endodontic Sealer Delivery System consists of Zinc Oxide/Eugenol dental cement packaged in a delivery cartridge consisting of a type 304 stainless steel tube insert molded into a nylon cartridge. A sealer cartridge is loaded into a carridge-type syringe. The tube is inserted into the prepared canal. The cernent is expressed directly into the canal by squeezing the pressure activation handle while slowly withdrawing the probe from the canal. The cement is allowed to set. The empty cartridge is removed and discarded.
The provided 510(k) summary for the "Max-i-Probe Endodontic Sealer Delivery System" does not include a study proving device acceptance criteria in the manner typically found in more recent submissions involving performance testing with quantitative metrics. Instead, the acceptance is based on demonstrating substantial equivalence to a predicate device.
Here's an analysis of the submission given the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
Since this is a substantial equivalence determination based on predicate devices, specific numerical acceptance criteria and performance metrics from a dedicated study are not provided in the document. The acceptance is implied by the equivalence to the predicate.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Material Equivalence | The manufacturing materials and processes are the same or equivalent as the predicate device (Roth International Ltd. Root Canal Cement, Type 801 Elite Grade/Eugenol USP). |
| Functional Equivalence | The functionality of the Max-i-Probe Endodontic Sealer Delivery System is the same or equivalent as the predicate device. |
| Intended Use Equivalence | Intended to be used in endodontic therapy by dental care professionals in a clinical setting to apply Zinc Oxide-Eugenol sealing cement to the inside surface of a prepared root canal prior to the introduction of gutta percha (or other restorative and filling materials), which is consistent with the predicate. |
| Sterility Assurance | Packaged in a sealed polypropylene cartridge pak and radiation sterilized to AMI guidelines. Sterility assurance level at least 10⁻⁶. Each lot is dosimetrically released. |
2. Sample Size Used for the Test Set and Data Provenance:
No specific test set or data provenance (e.g., country of origin, retrospective/prospective) is mentioned, as the submission relies on the established safety and effectiveness of the predicate device and the equivalence of the new device to it.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
Not applicable. The ground truth, in this context, refers to the established safety and effectiveness of the predicate device, not data from a new study with expert review.
4. Adjudication Method for the Test Set:
Not applicable. No new test set requiring adjudication is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size:
No MRMC study was conducted or referenced in this 510(k) summary. The submission focuses on device equivalence, not comparative effectiveness with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable. The device is a physical delivery system for endodontic sealer, not an algorithm or AI system.
7. The Type of Ground Truth Used:
The "ground truth" for this submission is the established safety and effectiveness of the legally marketed predicate device (Roth International Ltd. Root Canal Cement, Type 801 Elite Grade/Eugenol USP). The new device's materials, manufacturing processes, and function are asserted to be equivalent to this predicate.
8. The Sample Size for the Training Set:
Not applicable. This is not an AI/ML device, so there is no training set in the conventional sense.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. There is no training set mentioned.
§ 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.