(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.
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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 and Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 8, 2021
Beijing C-Root Dental Medical Devices Co., LTD. Boyle Wang Official Correspondent Shanghai Truthful Information Technology Co., Ltd. RM.1801 ,No.161, East Lu Jiazui Rd., Pudong Shanghai, Shanghai 200120 China
Re: K212983
Trade/Device Name: Injectable Root Canal Bioceramic Sealer Regulation Number: 21 CFR 872.3820 Regulation Name: Root Canal Filling Resin Regulatory Class: Class II Product Code: KIF Dated: November 26, 2021 Received: December 6, 2021
Dear Boyle Wang:
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
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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 (OS) 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,
For 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
510(k) Number (if known)
K212983
Device Name Injectable Root Canal Bioceramic Sealer
Indications for Use (Describe)
-
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.
| Type of Use (Select one or both, as applicable) | ||
|---|---|---|
| ☒ Prescription Use (Part 21 CFR 201 Subpart D)☐ Over-The-Counter Use (21 CFR 201 Subpart C) | ☒ Prescription Use (Part 21 CFR 201 Subpart D) | ☐ Over-The-Counter Use (21 CFR 201 Subpart C) |
| ☒ Prescription Use (Part 21 CFR 201 Subpart D) | ||
| ☐ Over-The-Counter Use (21 CFR 201 Subpart C) |
Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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K212983 510(k) Summary
This summary of 510(k) substantial equivalence is being submitted in accordance with requirements of 21 CFR 807.92.
1.0 Submitter's Information
Name: Beijing C-Root Dental Medical Devices Co., LTD Address: Room 301, Building 10, Yard 12, Middle Juyuan Road, Mapo Town, Shunyi District, Beijing, China Tel: +86-18601290788 Fax: 86- 10-51727496 Contact: Bingmin Wu Date of Preparation: Aug.25,2021
Designated Submission Correspondent
Mr. Boyle Wang Shanghai Truthful Information Technology Co., Ltd. Room 1801, No. 161 East Lujiazui Rd., Pudong Shanghai, 200120 China Tel: +86-21-50313932 Email: Info@truthful.com.cn
2.0 Device Information
Trade name: Injectable Root Canal Bioceramic Sealer Common name: Root Canal Sealer Classification name: Resin, Root Canal Filling Model: C-Root SP
3.0 Classification
Production code: KIF Regulation number: 21 CFR 872.3820 Classification: Class II Panel: Dental
4.0 Identification of Predicate Device and Reference Device
Predicate Device:
510(k) Number: K080917 Product Name: iRoot SP
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Manufacturer: Innovative BioCeramix, Inc.
5.0 Indication for Use Statement
- Permanent obturation of the root canal following vital pulp-extirpation.
- · 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.
6.0 Device Description
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.
7.0 Summary of Non-Clinical Testing
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
ISO 6876:2012 Dentistry - Root canal sealing materials.
Biocompatibility testing
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- Ames Test ISO 10993-3:2014 Biological evaluation of medical devices Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity.
- -Mouse Lymphoma Cells(TK) Gene Mutation Test- ISO 10993-3:2014 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity.
- In Vitro Cytotoxicity Test ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
- Sensitization ISO 10993-10:2010 Biological evaluation of medical devices -Part 10: Tests for irritation and skin sensitization
- Intracutaneous Reactivity Test ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
- Acute systemic Toxicity Test ISO 10993-11:2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
- Subchronic systemic Toxicity Test ISO 10993-11:2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
- Bone Implantation effects ISO 10993-6:2016 Biological evaluation of the medical devices – Part 6: Tests for Local Effects after Implantation.
- -Endodontic usage Test- ISO 7405:2018 Dentistry Evaluation of biocompatibility of medical devices used in dentistry
8.0 Summary of Clinical Testing
Clinical testing was not required for this submission.
9.0 Technological Characteristics and Substantial Equivalence
The following table shows similarities and differences of use, design, and material between our device and the predicate devices.
Table 1 General Device Characteristics Comparison Table
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| Item | Subject device | Predicate deviceK080917 | Remark |
|---|---|---|---|
| Product Name | Injectable Root CanalBioceramic Sealer | iRoot SP | -- |
| Product Code | KIF | KIF | Same |
| Regulation No. | 21 CFR 872.3820 | 21 CFR 872.3820 | Same |
| Class | II | II | Same |
| Intended Use | • Permanent obturation ofthe root canal following vitalpulp-extirpation.• Permanent obturation ofthe root canal followingremoval of infected ornecrotic pulp and placementof intracanal dressings.C-Root SP Injectable RootCanal Bioceramic Sealer issuitable for use in the singlecone and lateralcondensation technique. | * Permanent obturation ofthe root canal followingvital pulp-extirpation.* Permanent obturation ofthe root canal followingremoval of infected ornecrotic pulp andplacement of intracanaldressings.iRoot SP is suitable foruse in the single coneand lateral condensationtechnique. | Same |
| PrescriptionUse | Yes | Yes | Same |
| BasicChemicalComposition | Zirconium Oxide,Strontium Silicates,Calcium Phosphates,Calcium Hydroxide,Tantalum Oxide and FillerAgents. | Zirconium Oxide,Calcium Silicates,Calcium Silicates,Calcium PhosphateMonobasic and FillerAgents | Similar |
| PerformanceStandardConformance | Conformed to ISO 6876and conformed toTechnical Requirements of"Injectable Root CanalBioceramic Sealer"addingAppearance,Dimensionalchange following setting,pH. | Conformed to ISO 6876 | Same |
| TreatmentSite | Root canal following vitalpulp-extirpation | Root canal following vitalpulp-extirpation | Same |
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| Sterile | Non-sterile | Non-sterile | Same |
|---|---|---|---|
| Biocompatibility | Comply with ISO 10993-1:2018, FDA Guidance, tests included cytotoxicity, irritation, sensitization, acute systemic toxicity, subchronic systemic toxicity test, implantation effect , endodontic usage test , Ames test and TK test. | Comply with ISO 10993-1, FDA Guidance | Same |
| Label and Labeling | Conforms to FDA Regulatory Requirements | Conforms to FDA Regulatory Requirements | Same |
Analysis:
iRoot SP Root Canal Sealer was identified as the predicate device due to the subject device having similar materials and delivery form (i.e. premixed ready-to-use injectable paste) to the predicate. The predicate device is composed of Zirconium oxide, a radiopaque agent and thickening agents as does the subject device. The subject device uses strontium silicates, the predicate device uses calcium silicates, strontium silicates and calcium silicates are all belong to silicate and can be set and harden upon the moisture in the dentin. Also, strontium silicates have better radiation resistance than calcium silicates. Also, the biocompatibility testing completed in alignment ISO 10993-1 and ISO 7405:2018 respectively demonstrate that any material differences between the subject device and predicate device do not raise any new questions as to safety and effectiveness.
Performance comparison testing was conducted to the predicate device and current device to compare their performance according to the Technical Requirements of "Injectable Root Canal Bioceramic Sealer", which is identical to ISO 6876,and at the same time, adding the requirements on Appearance, Dimensional change following setting and pH. And the comparison testing results shown both the subject device and the predicate device are complied with Technical Requirements of "Injectable Root Canal Bioceramic Sealer".
Therefore, it is concluded that the subject device is substantially equivalent to the predicate device.
10.0 Conclusion
The conclusions drawn from the comparison and analysis above demonstrate that the differences between the proposed device and the predicated device are insignificant in terms of substantial equivalence. The subject device is
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substantially equivalent to the predicate device in K080917.
§ 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.