C-Root BP Bioceramic Root Repair Material (C-Root BP) is a convenient ready-to-use premixed bioceramic paste developed for permanent root canal repair and surgical applications. C-Root BP is an insoluble, radiopaque and aluminum-free material based on a strontium silicate composition, which requires the presence of water to set and harden. C-Root BP does not shrink during setting and demonstrates excellent physical properties. C-Root BP is packaged in a Preloaded syringe.

AI/ML Overview

The provided document is a 510(k) summary for a medical device called "Bioceramic Root Repair Material (C-Root BP)". This document outlines the non-clinical testing performed to demonstrate that the subject device is substantially equivalent to a predicate device.

Here's an analysis of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document provides two tables summarizing non-clinical performance testing.

Table 1: Summary of non-clinical performance testing according to the ISO 6876:2012

Test	Acceptance Criteria (from ISO 6876:2012)	Subject Device (C-Root BP) Performance	Predicated Device (iRoot BP Plus) Performance
Setting time	Shall not exceed 72h.	2h	17h
Solubility	Shall not exceed 3.0 % by mass.	1.4%	1.71%
	Specimen shall show no evidence of disintegration when examined visually.	Meets requirement	Meets requirement
Radio-opacity	Equivalent to not less than 3mm of aluminum.	Meets requirement	Meets requirement

Table 2: Summary of non-clinical performance testing according to the Technical Requirements of "Bioceramic Root Repair Material" provided by our company

Test	Acceptance Criteria	Subject Device (C-Root BP) Performance	Predicated Device (iRoot BP Plus) Performance
Appearance	Milky white paste, visually free from extraneous matter under normal visual acuity.	Meets requirement	Meets requirement
Dimension changes after setting	Measured mean dimensional change in length shall not exceed 1.0% in shrinkage or 0.1% in expansion.	-0.44%	-0.48%
pH	The pH of the sealer material should be greater than 11.	12.68	12.27

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample sizes used for the non-clinical performance tests. The data provenance is implied to be from laboratory testing conducted within the context of the manufacturer (Beijing C-Root Dental Medical Devices Co., LTD.) for both the subject device and the predicate device. It is therefore retrospective data collected specifically for this submission. The country of origin of the data is China, as the manufacturer is based in Beijing, China.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts

This information is not provided in the document. The "ground truth" for these tests refers to the objective measurement against established standards (ISO 6876:2012 and internal technical requirements), rather than expert consensus on clinical cases. Therefore, experts in dental product testing and metrology would be implied, but their number and specific qualifications are not detailed.

4. Adjudication Method for the Test Set

This is not applicable as the non-clinical tests involve objective measurements against specific criteria rather than subjective assessments requiring 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. The device is a "Bioceramic Root Repair Material," not an AI-powered diagnostic or decision-support tool for human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance is irrelevant to this device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

This is not applicable. The device is a physical material, not an algorithm.

7. The Type of Ground Truth Used

The ground truth used for the non-clinical performance tests comprises defined standards and criteria:

ISO 6876:2012: An international standard for root canal sealing materials.
Technical Requirements of "Bioceramic Root Repair Material": Internal company-defined standards.
This is not based on expert consensus, pathology, or outcomes data in the clinical sense, but rather on physical and chemical property measurements against established benchmarks.

8. The Sample Size for the Training Set

This is not applicable. The device is a physical material, not a machine learning model that requires a training set.

9. How the Ground Truth for the Training Set was Established

This is not applicable as there is no training set for this type of device.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".

May 10, 2024

Beijing C-Root Dental Medical Devices Co., Ltd. Bingmin Wu Official Correspondent Room 301, Building 10, Yard 12 Middle Juyuan Road, Mapo Town, Shunyi Beijing, 101300 China

Re: K240365

Trade/Device Name: Bioceramic Root Repair Material (C-Root BP) Regulation Number: 21 CFR 872.3820 Regulation Name: Root Canal Filling Resin Regulatory Class: Class II Product Code: KIF Dated: November 25, 2023 Received: February 6, 2024

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

Bobak Shirmohammadi -S

For Michael E. Adjodha, M.ChE., RAC, CQIA Assistant Director DHT1B: Division of Dental and ENT Devices

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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)

K240365

Device Name

Bioceramic Root Repair Material (C-Root BP)

Indications for Use (Describe)

·Repair of Root Perforation

·Repair of Root Resorption

·Root End Filling

· Apexification

· Pulp Capping

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) Summary

K240365

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: Apr.23,2024

2.0 Device Information

Trade name: C-Root BP Common name : Bioceramic Root Repair Material Classification name: Resin, Root Canal Filling Model: C-Root BP Production code:KIF Regulation number:21 CFR 872.3820 Classification:Class II Panel:Dental Manufacturer: Beijing C-Root Dental Medical Devices Co., LTD.

3.0 Identification of Predicated Device and Reference device

Primary Predicate Device:

510(k) Number: K092715

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510(k) Summary

Product Name: iRoot BP Plus Common Name:Bioceramic Root Repair Material Production code:KIF Requlation number:21 CFR 872.3820 Classification:Class II Panel:Dental Manufacturer: Innovative BioCeramix, Inc.

Reference device: 510(k) Number: K212983 Product Name: Injectable Root Canal Bioceramic Sealer Common Name:Root Canal Sealer Model: C-Root SP Production code:KIF Regulation number:21 CFR 872.3820 Classification:Class II Panel:Dental Manufacturer:Beijing C-Root Dental Medical Devices Co., LTD.

4.0 Indication for Use Statement

Repair of Root Perforation
Repair of Root Resorption
Root End Filling ●
Apexification
Pulp Capping

5.0 Device Description

C-Root BP Bioceramic Root Repair Material (C-Root BP) is a convenient ready-to-use premixed bioceramic paste developed for permanent root canal repair and surgical

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applications. C-Root BP is an insoluble, radiopaque and aluminum-free material based on a strontium silicate composition, which requires the presence of water to set and harden. C-Root BP does not shrink during setting and demonstrates excellent physical properties. C-Root BP is packaged in a Preloaded syringe.

6.0 Summary of Non-Clinical Testing

Non clinical tests were conducted to verify that the subject device C-Root BP met all design specifications as was Substantially Equivalent (SE) to the predicated device.

Mechanical Performance Comparison Testing:

The following test data was gathered according to the ISO 6876:2012 testing for the subject and predicated devices: see summary table 1 below:

	Table 1 Summary of non-clinical performance testing according to the ISO 6876:2012
--	------------------------------------------------------------------------------------	--	--	--

Test	Criteria	SubjectDeviceC-Root BP	PredicatedDeviceiRoot BP Plus
Setting time	When determined in accordance with3.3, the setting time of the sealingmaterial measured shall not exceed 72h.	2h	17h
Solubility	When determined in accordance with3.6, the solubility of setting sealingMeasured shall not exceed 3.0 % bymass.The specimen shall show no evidence ofdisintegration when examined visually.	1.4%	1.71%

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Radio-opacity	When determined in accordance with 3.7, the sealing material shall have a radio-opacity equivalent to not less than 3mm of aluminium	Meets requirement	Meets requirement
---------------	--------------------------------------------------------------------------------------------------------------------------------------	-------------------	-------------------

As defined in the testing data from the Subject and predicated device the ISO 6876:2012 was used and followed for most parts.

Some of the testing recommended by the standard ISO 6876:2012, such as the flow/working time/ film thickness are not suitable for the subject device and predicate device.Because the intend use such as repair and root end filling need putty stable and can not flow.

In addition, Additional tests including Appearance, Dimension changes after setting and pH were performed per the Technical Requirements of "Bioceramic Root Repair Material" provided by our company.

Summary of non-clinical performance testing according to the Technical Table 2 -Requirements of "Bioceramic Root Repair Material" provided by our company

Test	Criteria	Subject Device	Predicated Device
		C-Root BP	iRoot BP Plus
Appearance	The sealer material is milky white paste, and shall be visually free from extraneous matter when examined under normal visual acuity.	Meets requirement	Meets requirement
Dimension changes after setting	Measured mean dimensional change in length of this sealer shall not exceed 1.0% in shrinkage or 0.1% in expansion.	-0.44%	-0.48%
pH	The pH of the sealer material should be greater than 11.	12.68	12.27

All the non clinical tests results verify that the subject device C-Root BP and the predicated 4 / 8

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510(k) Summary

device meet the product acceptance criteria.

Biocompatibility:

Biocompatibility testing was performed in accordance with the ISO 10993-1,ISO 7405 and FDA guidance document Use of International Standard ISO 10993-1, "Biological Evaluation of Medical Devices - Part 1: Evaluation and testing within a risk management process." Testing included the following:

· Cytotoxicity (ISO 10993-5:2009)
· Sensitization (ISO 10993-10:2021)
· Intracutaneous Irritation (ISO 10993-23:2021)
· Acute Systemic Toxicity(ISO 10993-11: 2017)
· Subchronic Systemic Toxicity (ISO 10993-11: 2017)
· Bacterial Reverse Mutation Test(ISO 10993-3:2014)
Mammalian Cell Gene Mutation Test(ISO 10993-3:2014)
· Pulp Capping Testing(ISO7405:2008)
· Implantation Tests(ISO10993-6:2016)

All the results of biocompatibility testing demonstrate that the subject devices are complied with the biocompatibility requirements.

Since the chemical composition of the subject device C-Root BP is based on principal chemical components in C-Root SP(K212983), the biocompatibility test data of C-Root SP provide further evidence of biocompatibility and over all safety for C-Root BP,

7.0 Summary of Clinical Testing

Clinical testing was not required for this submission.

8.0 Technological Characteristics and Substantial Equivalence 5 / 8

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The following table shows similarities and differences of use, design, and material between the subject device and the predicated devices.

Table 3 General Device Characteristics Comparison

Item	Subject deviceK240365	Predicated deviceK092715	Reference deviceK212983	Remark
Product name	C-Root BP	iRoot BP Plus	InjectableRootCanalBioceramicSealer	--
510K Number	K240365	K092715	K212983
Product Code	KIF	KIF	KIF	Same
Regulation No.	21 CFR 872.3820	21 CFR 872.3820	21 CFR 872.3820	Same
Class	II	II	II	Same
Intended Use	•Repair of RootPerforation•Repair of RootResorption•Root End Filling•Apexification•Pulp Capping	•Repair of RootPerforation•Repair of RootResorption•Root End Filling•Apexification•Pulp Capping	Permanentobturation of the rootcanal following vitalpulp-extirpation.Permanentobturation of the rootcanal followingremoval of infectedor necrotic pulp andplacement ofintracanal dressings.	Same asPredicatedevice
PrescriptionUse	Yes	Yes	Yes	Same
BasicChemicalComposition	Zirconium Oxide,StrontiumSilicate,Calcium Phosphates	calcium silicates,Zirconium oxide,tantalum pentoxide,	Zirconium Oxide,Strontium Silicate,CalciumPhosphates,	Analysis 1
	Calcium Hydroxide,Tantalum Oxideand filler agents.	Calciumsulfate(anhydrous)calcium phosphatemonobasic, filleragents	Calcium Hydroxide,Tantalum Oxideand filler agents.
PerformanceStandardConformance	Appearance,Setting time,Dimensional changefollowing setting,Solubility,Radio-opacity,pH, Microorganism	Appearance,Setting time,Dimensional changefollowing setting,solubility,Radio-opacity andpH	Appearance,Flow,Film thickness,setting time,dimensional changefollowing setting,solubility,Radio-opacity, pH ,Microorganism	Same asPredicateddevice
TreatmentSite	Root canal	Root canal	Root canal	Same
Sterile	Non-sterile	Non-sterile	Non-sterile	Same
Biocompatibility	Comply with ISO10993-1 and FDAguidance	Comply with ISO10993-1:2018 FDAguidance	Comply with ISO10993-1:2018 FDAguidance	Same
Label andLabeling	Conforms to FDARegulatoryRequirements	Conforms to FDARegulatoryRequirements	Conforms to FDARegulatoryRequirements	Same

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Analysis:

1.The subject device C-Root BP has the same intended use and comparable materials as the predicated device iRoot BP Plus (K092715 ).

Chemical composition of the subject device C-Root BP is different with that of the predicated device. The subject device uses strontium silicate whereas the predicated device uses calcium silicates. Strontium silicate and calcium silicates are all belong to silicate and

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can be set and harden upon the moisture in the dentin. Also, strontium silicate has better radiation resistance than calcium silicates.

The subject device C-Root BP has the same formulation component / processing / non-sterilization /principal of setting / final form after setting as the Reference device C-Root SP (K212983), and no other chemical filler agent has been added.

All the raw materials of the subject device C-Root BP including strontium silicate are all used in the reference device (K212983). Biocompatibility testing of the subject device C-Root BP and the reference device (K212983) performed meet ISO 10993 biocompatibility and FDA guidance requirements.

Also, the performance comparison testing including appearance, setting time, dimension changes after setting, solubility, radiopacity, pH of C-Root BP and iRoot BP Plus provide the evidence that chemical and physical properties are substantially equivalent.

9.0 Conclusion

The conclusions drawn from the comparison and analysis above demonstrate that the differences between the subject device C-Root BP and the predicated device iRoot BP Plus are insignificant in terms of substantial equivalence. The subject device C-Root BP is substantially equivalent to the predicate device iRoot BP Plus.

Regulation Number and Section

§ 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.