(242 days)
- A root-end filling material
- For the repair of root canals as an apical plug during apexification
- For repair of root perforations during root canal therapy
- As a consequence of internal resorption
- As a pulp capping material
- For the filling of pulpotomy of deciduous tooth
This product is designed for vital pulp therapies like direct pulp capping treatment. It effectively prevents secondary infection as well as pulp irritation.
The provided text describes a 510(k) summary for the medical device ENDOCEM MTA (Mineral Trioxide Aggregate). The submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study with acceptance criteria for device performance in a clinical setting.
Therefore, many of the requested sections below are not applicable because the submission relies on demonstrating comparable physical and biocompatible properties to a predicate device, not on proving clinical efficacy against specific acceptance criteria in a study.
1. Table of Acceptance Criteria and Reported Device Performance
Not applicable. The submission does not define specific "acceptance criteria" in terms of clinical performance metrics (e.g., sensitivity, specificity, accuracy) for the device. Instead, the acceptance criteria for the device evaluation were based on meeting ISO 6876 standards for physical properties and demonstrating similar physical and biocompatible properties to the predicate device.
| Acceptance Criteria (from ISO 6876) | Reported Device Performance |
|---|---|
| Setting time | Met test criteria |
| Solubility | Met test criteria |
| Dimensional change following setting | Met test criteria |
| Radiopacity | Met test criteria |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This submission does not describe a clinical "test set" in the context of an effectiveness study. The evaluation focused on bench testing (physical characteristics) and biocompatibility, comparing the new device to a predicate device. Information on sample sizes for these tests (e.g., number of samples for setting time measurement) is not provided in the summary.
The data provenance is from bench and biocompatibility testing performed by the manufacturer, MARUCHI, located in South Korea. The study is not a retrospective or prospective clinical study on human subjects.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. No clinical "test set" requiring ground truth established by experts is described in this submission. The evaluation was based on standardized physical property tests (ISO 6876) and biocompatibility assessments, not on interpretation of clinical data by experts.
4. Adjudication Method for the Test Set
Not applicable. As there is no clinical "test set" requiring ground truth established by experts, no adjudication method was used.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. A MRMC comparative effectiveness study was not done. The submission is a 510(k) for substantial equivalence based on physical and biocompatibility properties, not a clinical efficacy study involving human readers.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not applicable. This device is a dental material (root filling material), not a software algorithm or an AI-powered system that would have "standalone performance" in the context of an algorithm's output without human intervention.
7. The Type of Ground Truth Used
The "ground truth" for the device evaluation was based on:
- ISO 6876 standards: For physical properties like setting time, solubility, dimensional change, and radiopacity. The values defined by this international standard serve as the reference.
- Predicate device properties: The submission states that the new device has "similar physical and biocompatible properties" and "comparable performance specifications" to the predicate device (MTA MATERIAL, K981620). The properties of the predicate device, demonstrated to be safe and effective, represent an implicit "ground truth" for equivalence.
8. The Sample Size for the Training Set
Not applicable. This submission describes a new medical device, not an AI or machine learning algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set for an algorithm, the concept of establishing ground truth for a training set does not apply.
§ 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.