i-MTA BP Bioceramic Root Canal Sealer and Repair Materials is a ready-to-use premixed bioceramic paste developed for permanent root canal sealer and repair and surgical applications. i-MTA BP is an insoluble, radiopaque and aluminum-free material based on a calcium silicate composition, which requires the presence of water to set and harden. i-MTA BP does not shrink during setting and demonstrates excellent physical properties. i-MTA BP is packaged in a preloaded syringe.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study details for the Bioceramic Root Canal Sealer and Repair Materials (i-MTA BP), based on the provided FDA 510(k) summary:

This device is not an AI/ML device, therefore, some of the requested information (like effect size of human readers with vs. without AI, number of experts for ground truth, adjudication methods, details on training set) are not applicable. The information provided relates to a traditional medical device's performance against established standards.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Requirement)	Standard/Guideline	Reported Device Performance (i-MTA BP)
Physical/Chemical Properties:
Setting time	ISO 6876:2012	2.5h (within 2h-6h)
Solubility	ISO 6876:2012	2.80% (< 3%)
Radio-opacity	ISO 6876:2012	> 3mm Al (> 3mm Al)
Composition (visual foreign objects)	Technical Specifications	Compliant with requirements
Content (of indicated loading capacity)	Technical Specifications	Compliant with requirements (>93%)
Size change after curing	Technical Specifications (ISO6876:2001)	-0.50% (< 1.0%)
pH	Technical Specifications	12.29 (within 11.5-13.5)
Acid-soluble arsenic content	Technical Specifications	Compliant with requirements (< 2mg/kg)
Acid-soluble lead content	Technical Specifications	Compliant with requirements (< 100mg/kg)
Heavy metal content	Technical Specifications	< 100 µg/g (< 100 µg/g)
Biocompatibility:
Cytotoxicity	ISO 7405:2018	Compliant
Sensitization	ISO 10993-10:2021	Compliant
Irritation	ISO 10993-10:2021	Compliant
Acute Systemic Toxicity	ISO 10993-11:2017	Compliant
TK Gene Mutation Test	ISO 10993-3:2014	Compliant
Bacterial Reverse Mutation Test	ISO 10993-3:2014	Compliant
Subchronic Systemic Toxicity	ISO 10993-11:2017	Compliant
Implantation	ISO 10993-6:2016	Compliant
Pulp Capping Testing	ISO7405:2018	Compliant
Endodontic Usage Test	ISO 7405:2018	Compliant

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

The document does not explicitly state the sample sizes used for each specific performance test (e.g., how many samples were tested for setting time, solubility, etc.). The provenance of the data is not specified beyond being generated from "Performance testing - Bench" and "Biocompatibility Testing" which implies laboratory testing directly on the subject device. There is no indication of retrospective or prospective clinical data from specific countries for these bench tests.

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

This information is not applicable to the type of device and testing presented. The "ground truth" for this device is based on objective measurements against international and technical standards, not expert consensus on medical images or diagnoses.

4. Adjudication Method for the Test Set

Not applicable. The tests involve objective measurements against predefined criteria, not subjective interpretation requiring adjudication among experts.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study is typically for diagnostic imaging devices where human readers interpret medical images. This device is a dental material, and its performance is evaluated by bench testing and biocompatibility.

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

Yes, the device's performance was evaluated in a standalone manner (without human-in-the-loop performance) through bench testing and biocompatibility studies. As it is a physical material, there is no "algorithm" involved, but its intrinsic properties were tested directly.

7. The Type of Ground Truth Used

The ground truth used for performance validation is objective measurement against established international standards (e.g., ISO 6876:2012, ISO 10993 series, ISO 7405:2018) and internal Technical Specifications.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable, as there is no training set for this type of device.

Summary

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December 12, 2024

Longly Biotechnology (Wuhan) Co., Ltd. % Shirely Kong RA Beijing Xinranyicheng Medicine & Technology Co., Ltd. A-15B01, Langqin International Building, No.168, Guang'anmen Outer Street, Xicheng District Beijing, Beijing 100053 China

Re: K242934

Trade/Device Name: Bioceramic Root Canal Sealer and Repair Materials (i-MTA BP) Regulation Number: 21 CFR 872.3820 Regulation Name: Root Canal Filling Resin Regulatory Class: Class II Product Code: KIF. Dated: September 14, 2024 Received: September 25, 2024

Dear Shirely Kong:

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.

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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" (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 (OS) 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 QS 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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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 medical devices and radiation-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-regulatory

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assistance/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,

Image /page/2/Picture/3 description: The image contains the name "Bobak Shirmohammadi" stacked on top of each other. Below the name is the character string "-S". To the left of the name is a faded image of the letters "FDA".

For Michael E. Adjodha, MChE, RAC, CQIA 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) K242934

Device Name

Bioceramic Root Canal Sealer and Repair Materials

Indications for Use (Describe)

i-MTA BP Bioceramic Root Canal Sealer and Repair Material is developed for permanent root canal sealer and repair and surgical applications.

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

Type of Use (Select one or both, as applicable)

|X Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary K242934

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: Longly Biotechnology (wuhan) Co., Ltd Address: No.02 of 2nd Floor, Building A2-2, Optics Valley Biomedical Park, Gaoxin Avenue No.858, East Lake High-tech Development Zone, Wuhan, China Tel: +86 - 13907166169 Contact: Yan Liang (Registration manager) Email: longlyyanliang466@163.com Date of Preparation: Sep.8,2024

2.0 Device Information

Trade Name: Bioceramic Root Canal Sealer and Repair Materials Model: i-MTA BP Common Name: Root canal filling resin Classification Name: Resin, Root Canal Filling Device Panel: Dental Classification Regulation: 21 CFR 872.3820 Device Classification: Class II Product Code: KIF

3.0 Identification of Predicate Device and Reference Device

Information	Predicate Device	Reference Device
510(k) Number	K240365	K092715
Device Name	Bioceramic Root Repair Material(C-Root BP)	IROOT BP PLUS
Common Name	Bioceramic Root Repair Material	Root Repair Material
Classification Name	Resin, Root Canal Filling	Resin, Root Canal Filling
Device Panel	Dental	Dental
Classification Regulation	21 CFR 872.3820	21 CFR 872.3820
Device Classification	Class II	Class II
Product Code	KIF	KIF
Manufacturer	Beijing C-Root Dental MedicalDevices Co., LTD.	Innovative BioCeramix, Inc.

4.0 Device Description

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5.0 Indication for Use

i-MTA BP Bioceramic Root Canal Sealer and Repair Material is developed for permanent root canal sealer and repair and surgical applications.

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

6.0 Comparison of Product Properties with the Predicate Device

The subject device Bioceramic Root Canal Sealer and Repair Materials(i-MTA BP) met all design specifications as was Substantially Equivalent (SE) to the predicated device.

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510(k) Summary

ComparisonItems	Subject Device	Predicate Device	Reference Device	Comparison
K Number	K242934	K240365	K092715	--
Trade name	Bioceramic Root Canal Sealer and RepairMaterials	Bioceramic Root Repair Material	IROOT BP PLUS	--
Model	i-MTA BP	C-Root BP	iRoot BP Plus	--
Classificationname	Resin, Root Canal Filling	Resin, Root Canal Filling	Resin, Root Canal Filling	Same
Product code	KIF	KIF	KIF	Same
Class	II	II	II	Same
Intendeduse/Indicationsfor Use	• Root End Filling• Repair of Root Perforation• Repair of Root Resorption• Apexification• Pulp Capping	• 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	Same
Targeted Site	Root canal	Root canal	Root canal	Same
PrescriptionUse	Yes	Yes	Yes	Same
ChemicalComposition	Calcium silicate, zirconium oxide, tantalumpentoxide, calcium sulfate and filler agents.	Zirconium oxide, strontiumsilicate, calcium phosphates, calciumhydroxide, tantalum oxide and filleragents.	Tricalcium silicate, dicalcium silicate,zirconium oxide, tantalum pentoxide,calcium sulfate and filler agents.	Analysis 1
PerformanceStandardConformance	Standards or otherguidelines/ referentialused	Standards or otherguidelines/ referentialused	Standards or otherguidelines/ referentialused	Same aspredicateddevice
	ISO 6876:2012	ISO 6876:2012	ISO 6876:2012
	ISO 6876:2012	ISO 6876:2012	ISO 6876:2012
	ISO 6876:2012	ISO 6876:2012	ISO 6876:2012
	Technical Specifications	Technical Requirements	Technical Requirements
	Setting time	Setting time	Setting time
	Solubility	Solubility	Solubility
	Radio-opacity	Radio-opacity	Radio-opacity
	Composition	Appearance	Appearance
ComparisonItems	Subject Device	Predicate Device	Reference Device	Comparison
	Technical Specifications
	TechnicalSpecifications=ISO6876:2001	Technical Requirements	Technical Requirements
	Technical Specifications
	Technical Specifications	Technical Requirements	Technical Requirements
	Technical Specifications
		Dimensionchanges aftersetting	Dimensionchanges aftersetting
	Content
	Size change aftercuring
	pH	pH	pH
	Acid-solublearsenic and leadcontents
	Heavy metal
Duration ofContact	Permanent contact - contact exceeds 30d	Permanent contact - contact exceeds 30d	Permanent contact - contact exceeds 30d	Same
Biocompatibility	Comply with ISO 10993-1, ISO 7405 andFDA Guidance	Comply with ISO 10993-1, ISO 7405 andFDA Guidance	Comply with ISO 10993-1, ISO 7405 andFDA Guidance	Same

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510(k) Summary

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Analysis

1. The subject device Bioceramic Root Canal Sealer and Repair Materials(i-MTA BP) has the same intended use and comparable materials as the predicated device C-Root BP (K240365).
1. The chemical composition of the subject device Bioceramic Root Canal Sealer and Repair Materials is different with the predicated device C-Root BP (K240365).

The subject device uses calcium silicates whereas the predicated device uses strontium silicate. Calcium silicates and strontium silicates are all belong to silicate. The subject device uses calcium sulfate whereas the predicated device uses calcium phosphates and calcium hydroxide. They are all belong to calcium salt. They all can be set and harden upon the moisture in the dentin. They all play the same role in each's formula. Also, Calcium silicates have better biocompatibility. The subject device Bioceramic Root Canal Sealer and Repair Materials(i-MTA BP) has the same formulation/ processing/ non-sterilization/ principal of setting/ final form after setting as the

reference device iRoot BP Plus (K092715), and no other chemical composition has been added. All the raw materials of the subject device are all used in the reference device (K092715). Biocompatibility testing of the subject device and the reference device (K092715) performed meet ISO 10993 biocompatibility and FDA guidance requirements.

1. Also, the performance comparison testing including composition/appearance, setting time, size changes after curing, solubility, radiopacity, pH of 'Bioceramic Root Canal Sealer and Repair Materials' and C-Root BP provide the evidence that chemical and physical properties are substantially equivalent.

7.0 Summary of Testing

Performance Testing - Bench

Performance testing has been carried out to demonstrate that this device meets the performance specifications for its intended use. The following tests were performed on the device.

Standards or otherguidelines/ referentialused	Performances	Requirements	Complianceresult
ISO 6876:2012	Setting time	2h-6h	2.5h
ISO 6876:2012	Solubility	< 3%	2.80%
ISO 6876:2012	Radio-opacity	> 3mm Al	> 3mm Al
Technical Specifications	Composition	The product composition shouldnot contain any visible foreignobjects to the naked eye.	Compliant withrequirements
Technical Specifications	Content	Not less than 93% of the indicatedloading capacity.	Compliant withrequirements
TechnicalSpecifications=ISO6876:2001	Size changeafter curing	< 1.0%	-0.50%
Technical Specifications	pH	11.5-13.5	12.29
Technical Specifications	Acid-solublearsenic andlead contents	The maximum content of acid-soluble arsenic is 2mg/kg, themaximum content of acid-soluble	Compliant withrequirements

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		lead is 100mg/kg
Technical Specifications	Heavy metal	< 100 µg/g	< 100 µg/g

Clinical testing was not required for this submission.

Biocompatibility Testing

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 7405:2018)
· Sensitization (ISO 10993-10:2021)
Irritation (ISO 10993-10:2021)
· Acute Systemic Toxicity (ISO 10993-11: 2017)
· TK Gene Mutation Test (ISO 10993-3:2014)
· Bacterial Reverse Mutation Test (ISO 10993-3:2014)
· Subchronic Systemic Toxicity (ISO 10993-11: 2017)
Implantation (ISO10993-6:2016)
· Pulp Capping Testing (ISO7405:2018)
Endodontic Usage Test (ISO 7405:2018)

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

Summary

Bioceramic Root Canal Sealer and Repair Materials has the same Indications for Use and the principle of operations as the predicate device and reference device. It is intended purpose as they are placed into the root canal as a root filling material which met the requirement according to ISO 6876. It has similar physical and biocompatible properties and demonstrates comparable performance specifications to the predicate devices.

8.0 Conclusion

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

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.