Who is the manufacturer of Bioceramic Root Repair Material (C-Root BP)?

Beijing C-Root Dental Medical Devices Co., Ltd. filed the 510(k) submission for Bioceramic Root Repair Material (C-Root BP) (K240365).

What is the FDA product code for Bioceramic Root Repair Material (C-Root BP)?

KIF. It is classified under 21 CFR 872.3820 as a Class 2 device in the Dental panel.

What is the regulatory pathway for Bioceramic Root Repair Material (C-Root BP)?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like Bioceramic Root Repair Material (C-Root BP)?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Bioceramic Root Repair Material (C-Root BP)

K240365 · Beijing C-Root Dental Medical Devices Co., Ltd. · KIF · May 10, 2024 · Dental

Device Facts

Record ID	K240365
Device Name	Bioceramic Root Repair Material (C-Root BP)
Applicant	Beijing C-Root Dental Medical Devices Co., Ltd.
Product Code	KIF · Dental
Decision Date	May 10, 2024
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.3820
Device Class	Class 2
Attributes	Therapeutic

Intended Use

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

Device Story

C-Root BP is a ready-to-use, premixed bioceramic paste for permanent root canal repair and surgical applications. Composed of strontium silicate, zirconium oxide, calcium phosphates, calcium hydroxide, and tantalum oxide, the material is insoluble, radiopaque, and aluminum-free. It requires moisture from dentin to set and harden without shrinkage. The device is supplied in a preloaded syringe for clinical use by dental professionals. By providing a stable, biocompatible seal in root canals, the material facilitates healing in cases of perforation, resorption, or pulp exposure. It is used in a clinical setting to improve patient outcomes in endodontic procedures.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing, including mechanical performance (ISO 6876:2012) and biocompatibility (ISO 10993-1, ISO 7405). Bench tests compared setting time, solubility, radiopacity, dimensional changes, and pH against the predicate device, confirming performance within acceptable criteria.

Technological Characteristics

Bioceramic paste; strontium silicate, zirconium oxide, calcium phosphates, calcium hydroxide, tantalum oxide. Hardens via moisture-activated setting. Radiopaque, aluminum-free. Preloaded syringe form factor. Non-sterile. Conforms to ISO 6876:2012 for performance and ISO 10993/7405 for biocompatibility.

Indications for Use

Indicated for repair of root perforation, repair of root resorption, root end filling, apexification, and pulp capping in patients requiring endodontic treatment.

Regulatory Classification

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.

Predicate Devices

iRoot BP Plus (K092715)

Reference Devices

Injectable Root Canal Bioceramic Sealer (C-Root SP) (K212983)

Related Devices

K092715 — IROOT BP PLUS · Innovative Bioceramix, Inc. · Sep 28, 2009
K242934 — Bioceramic Root Canal Sealer and Repair Materials (i-MTA BP) · Longly Biotechnology (Wuhan) Co., Ltd. · Dec 12, 2024
K082943 — IROOT BP, MODEL IRBP 4609 · Innovative Bioceramix, Inc. · Jan 6, 2009
K212983 — Injectable Root Canal Bioceramic Sealer · Beijing C-Root Dental Medical Devices Co., Ltd. · Dec 8, 2021
K102867 — IROOT FS · Innovative Bioceramix, Inc. · Dec 3, 2010

Submission Summary (Full Text)

{0}------------------------------------------------ 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" {1}------------------------------------------------ (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 {2}------------------------------------------------ OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ #### 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ # 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 1 / 8 {5}------------------------------------------------ #### 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 {6}------------------------------------------------ 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 | Subject Device C-Root BP | Predicated Device iRoot BP Plus | |--------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------|---------------------------------------| | Setting time | When determined in accordance with 3.3, the setting time of the sealing material measured shall not exceed 72 h. | 2h | 17h | | Solubility | When determined in accordance with 3.6, the solubility of setting sealing Measured shall not exceed 3.0 % by mass. The specimen shall show no evidence of disintegration when examined visually. | 1.4% | 1.71% | {7}------------------------------------------------ | 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 {8}------------------------------------------------ #### 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 {9}------------------------------------------------ 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 device K240365 | Predicated device K092715 | Reference device K212983 | Remark | |----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------| | Product name | C-Root BP | iRoot BP Plus | Injectable Root Canal Bioceramic Sealer | -- | | 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 Root Perforation •Repair of Root Resorption •Root End Filling •Apexification •Pulp Capping | •Repair of Root Perforation •Repair of Root Resorption •Root End Filling •Apexification •Pulp Capping | 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. | Same as Predicate device | | Prescription Use | Yes | Yes | Yes | Same | | Basic Chemical Composition | Zirconium Oxide, Strontium Silicate, Calcium Phosphates | calcium silicates, Zirconium oxide, tantalum pentoxide, | Zirconium Oxide, Strontium Silicate, Calcium Phosphates, | Analysis 1 | | | Calcium Hydroxide, Tantalum Oxide and filler agents. | Calcium sulfate(anhydrous) calcium phosphate monobasic, filler agents | Calcium Hydroxide, Tantalum Oxide and filler agents. | | | Performance Standard Conformance | Appearance, Setting time, Dimensional change following setting, Solubility, Radio-opacity, pH, Microorganism | Appearance, Setting time, Dimensional change following setting, solubility, Radio-opacity and pH | Appearance,Flow, Film thickness, setting time, dimensional change following setting, solubility, Radio-opacity, pH , Microorganism | Same as Predicated device | | Treatment Site | Root canal | Root canal | Root canal | Same | | Sterile | Non-sterile | Non-sterile | Non-sterile | Same | | Biocompatibility | Comply with ISO 10993-1 and FDA guidance | Comply with ISO 10993-1:2018 FDA guidance | Comply with ISO 10993-1:2018 FDA guidance | Same | | Label and Labeling | Conforms to FDA Regulatory Requirements | Conforms to FDA Regulatory Requirements | Conforms to FDA Regulatory Requirements | Same | {10}------------------------------------------------ Analysis: 1.The subject device C-Root BP has the same intended use and comparable materials as the predicated device iRoot BP Plus (K092715 ). 2. 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 {11}------------------------------------------------ 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. 3. 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.