Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the material properties and physical performance of a bioceramic sealer, with no mention of AI or ML technology.

Therapeutic

Yes
The device is a root canal sealer used for permanent obturation of the root canal, which is a therapeutic intervention to treat and seal the root canal following vital pulp extirpation or removal of infected pulp.

Diagnostic

No

This device is a bioceramic sealer used for permanent obturation of root canals, which is a therapeutic rather than a diagnostic function.

SaMD (Software as a Medical Device)

No

The device is a physical material (bioceramic paste) packaged in a syringe with tips, intended for permanent root canal filling. It is not software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
Device Function: The C-Root SP Injectable Root Canal Bioceramic Sealer is a material used to fill and seal root canals within the tooth. It is applied directly to the anatomical site (root canal) and is not used to analyze a sample taken from the body.
Intended Use: The intended use is for permanent obturation (filling) of the root canal, which is a therapeutic procedure, not a diagnostic test.
Device Description: The description focuses on the material's properties and how it is delivered into the root canal.
Anatomical Site: The anatomical site is the root canal, which is part of the tooth structure, not a sample taken from the body.

Therefore, the C-Root SP Injectable Root Canal Bioceramic Sealer is a therapeutic medical device used in dentistry, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes

KIF

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 in 2g; 1g; 0.5g. The only difference between the types are the net weight.

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 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:

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

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".

Clinical testing was not required for this submission.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K080917

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

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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

1

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 device
K080917 | Remark |
|----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Product Name | Injectable Root Canal
Bioceramic 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 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. | * 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.
iRoot SP is suitable for
use in the single cone
and lateral condensation
technique. | Same |
| Prescription
Use | Yes | Yes | Same |
| Basic
Chemical
Composition | Zirconium Oxide,
Strontium Silicates,
Calcium Phosphates,
Calcium Hydroxide,
Tantalum Oxide and Filler
Agents. | Zirconium Oxide,
Calcium Silicates,
Calcium Silicates,
Calcium Phosphate
Monobasic and Filler
Agents | Similar |
| Performance
Standard
Conformance | Conformed to ISO 6876
and conformed to
Technical Requirements of
"Injectable Root Canal
Bioceramic Sealer"adding
Appearance,Dimensional
change following setting,pH. | Conformed to ISO 6876 | Same |
| Treatment
Site | Root canal following vital
pulp-extirpation | Root canal following vital
pulp-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.