(82 days)
- Permanent obturation of the root canal following vital pulpextirpation.
- Permanent obturation of the root canal following removal of infected or necrotic pulp and placement of intracanal dressings.
C-Root SP Injectable Root Canal Bioceramic Sealer is suitable for use in the single cone and lateral condensation technique.
C-Root SP Injectable Root Canal Bioceramic Sealer is a convenient premixed ready-to-use, injectable white hydraulic bioceramic paste developed for permanent root canal filling and sealing applications. C-Root SP is an insoluble, radiopaque and aluminum-free material based on a strontium silicates composition, which requires the presence of water to set and harden. C-Root SP does not shrink during setting and demonstrates excellent physical properties. C-Root SP is packaged in a preloaded syringe and is supplied with disposable Intra Canal tips. C-Root SP may be delivered into the canal via the disposable tips or it can be delivered via traditional methods.
C-Root SP Injectable Root Canal Bioceramic Sealer is available in three preloaded syringe mode that provide different in specification in2g; 1g; 0.5g. The only difference between the types are the net weight.
Based on the provided text, the device in question is an "Injectable Root Canal Bioceramic Sealer" and the submission is for a 510(k) premarket notification, which demonstrates substantial equivalence to a predicate device, not necessarily a claim of improved performance or a direct clinical efficacy study. Therefore, a significant portion of the requested information, particularly regarding AI performance, MRMC studies, and detailed ground truth establishment for a diagnostic AI, is not applicable to this type of medical device submission.
Here's the breakdown of the information that can be extracted and applied, with N/A for criteria that are not relevant to this submission:
1. A table of acceptance criteria and the reported device performance
For a 510(k) submission, "acceptance criteria" are typically defined by recognized standards (like ISO 6876:2012) and comparability to the predicate device. The performance is assessed through non-clinical testing.
| Acceptance Criteria (Set by Standards/Predicate Equivalence) | Reported Device Performance (Summary of Non-Clinical Testing) |
|---|---|
| Conformance to ISO 6876:2012 (Dentistry - Root canal sealing materials) | Conformed to ISO 6876:2012 |
| Appearance (added requirement) | Complied with Technical Requirements of "Injectable Root Canal Bioceramic Sealer" including Appearance. |
| Dimensional change following setting (added requirement) | Complied with Technical Requirements of "Injectable Root Canal Bioceramic Sealer" including Dimensional change following setting. |
| pH (added requirement) | Complied with Technical Requirements of "Injectable Root Canal Bioceramic Sealer" including pH. |
| Biocompatibility: Genotoxicity (Ames Test, Mouse Lymphoma Cells(TK) Gene Mutation Test) | Complied with ISO 10993-3:2014 |
| Biocompatibility: Cytotoxicity (In Vitro Cytotoxicity Test) | Complied with ISO 10993-5:2009 |
| Biocompatibility: Sensitization | Complied with ISO 10993-10:2010 |
| Biocompatibility: Intracutaneous Reactivity Test | Complied with ISO 10993-10:2010 |
| Biocompatibility: Acute systemic Toxicity Test | Complied with ISO 10993-11:2017 |
| Biocompatibility: Subchronic systemic Toxicity Test | Complied with ISO 10993-11:2017 |
| Biocompatibility: Bone Implantation effects | Complied with ISO 10993-6:2016 |
| Biocompatibility: Endodontic usage Test | Complied with ISO 7405:2018 |
| Material Composition (comparable to predicate) | Zirconium Oxide, Strontium Silicates, Calcium Phosphates, Calcium Hydroxide, Tantalum Oxide and Filler Agents (Similar to predicate's Zirconium Oxide, Calcium Silicates, Calcium Phosphate Monobasic and Filler Agents) |
| Intended Use (Same as predicate) | Same as predicate (Permanent obturation after vital pulpextirpation or removal of infected/necrotic pulp, suitable for single cone and lateral condensation) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable as the provided document details a 510(k) submission for a root canal sealer, which relies on non-clinical performance and biocompatibility testing, not a clinical study involving human patient data or a diagnostic AI's test set. The tests performed are laboratory-based assays on the material itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable. Ground truth establishment by experts relates to diagnostic device performance evaluation, particularly for AI/image analysis. This document describes a material-based device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable as there is no diagnostic test set requiring expert adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This is not applicable. This submission is for a material (root canal sealer), not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. There is no algorithm or standalone AI performance to evaluate.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For this device, "ground truth" refers to the established scientific and engineering principles and the performance standards outlined in ISO 6876:2012, as well as biocompatibility standards (e.g., ISO 10993 series). The "truth" is whether the material meets these specified physical, chemical, and biological properties in laboratory settings.
8. The sample size for the training set
This is not applicable. There is no machine learning model or "training set" for this type of device.
9. How the ground truth for the training set was established
This is not applicable. There is no machine learning model or "training set" for this type of device.
§ 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.