(94 days)
No
The device description and performance studies focus on the material properties and physical performance of a bioceramic paste, with no mention of AI or ML.
Yes
The device is a bioceramic paste intended for permanent root canal repair and surgical applications, which are therapeutic interventions.
No
This device is a bioceramic paste used for the repair and filling of root canals and other surgical applications, not for diagnosing conditions.
No
The device description clearly states it is a "premixed bioceramic paste" and is "packaged in a Preloaded syringe," indicating it is a physical material and delivery system, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended uses are all related to dental procedures performed within the body (repairing root perforations, root resorption, root end filling, apexification, pulp capping). IVDs are used to examine specimens from the body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The device is a material used for permanent root canal repair and surgical applications. This is a therapeutic or restorative function, not a diagnostic one.
- Anatomical Site: The anatomical site is the root canal, which is part of the body.
- No mention of analyzing specimens: There is no indication that this device is used to analyze any biological samples taken from the patient.
Therefore, C-Root BP Bioceramic Root Repair Material is a medical device used for dental procedures, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
- Repair of Root Perforation
- Repair of Root Resorption
- Root End Filling
- Apexification
- Pulp Capping
Product codes (comma separated list FDA assigned to the subject device)
KIF
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Root canal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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:
- Setting time: Subject Device C-Root BP: 2h; Predicated Device iRoot BP Plus: 17h. Criteria: not exceed 72h.
- Solubility: Subject Device C-Root BP: 1.4%; Predicated Device iRoot BP Plus: 1.71%. Criteria: not exceed 3.0 % by mass, no evidence of disintegration.
- Radio-opacity: Subject Device C-Root BP: Meets requirement; Predicated Device iRoot BP Plus: Meets requirement. Criteria: equivalent to not less than 3mm of aluminium.
Additional tests per Technical Requirements of "Bioceramic Root Repair Material":
- Appearance: Subject Device C-Root BP: Meets requirement; Predicated Device iRoot BP Plus: Meets requirement. Criteria: milky white paste, visually free from extraneous matter.
- Dimension changes after setting: Subject Device C-Root BP: -0.44%; Predicated Device iRoot BP Plus: -0.48%. Criteria: not exceed 1.0% in shrinkage or 0.1% in expansion.
- pH: Subject Device C-Root BP: 12.68; Predicated Device iRoot BP Plus: 12.27. Criteria: greater than 11.
Biocompatibility:
Testing performed in accordance with ISO 10993-1, ISO 7405, and FDA guidance document Use of International Standard ISO 10993-1:
- 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 non-clinical test results verify that the subject device C-Root BP and the predicated device meet the product acceptance criteria. All biocompatibility test results demonstrate that the subject devices are complied with the biocompatibility requirements.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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)
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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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 ).
- 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.
- 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.