Bright MTA Sealer Plus is a ready-to-use, injectable paste-like material for root canal filling, which is hardened and obturated after being injected into the root canal space. The product based on calcium silicate exhibits excellent biocompatibility as well as a low film thickness suitable for easy penetration of lateral and accessory canals.

AI/ML Overview

The provided text describes the acceptance criteria and performance data for a medical device called "Bright MTA Sealer Plus." However, it is not an AI-driven device; it is a root canal filling material. Therefore, some of the requested information, such as details on AI acceptance criteria, expert ground truthing, MRMC studies, or training/test sets for an AI model, are not applicable and thus not present in the document.

The document primarily focuses on the biocompatibility and mechanical performance of the "Bright MTA Sealer Plus" in comparison to a predicate device.

Here's a breakdown of the available information based on your request, with an explanation for elements that are not applicable:

Device Name: Bright MTA Sealer Plus

Device Type: Root canal filling material (Non-AI device)

1. Table of Acceptance Criteria and Reported Device Performance

The closest information available is in the "Mechanical testing" section:

No.	Items	Standard & Method	Acceptance Criteria	Result
1	Visual test	ISO 4049 Bare eyes	No alien substance and suitable for using the product	No alien substance and suitable for using the product
2	Capacity test	ISO 4049 Weight difference	Standard weight ± 5%	1.50 %
3	Package test	ISO 4049 Bare eyes	No damages, cracks	The package was completely sealed, and there were no damages, cracks.
4	Extraneous matter test	ISO 4049 Bare eyes	No extraneous matter	No Extraneous Matter
5	Flow test	EN ISO 6876: 2012 5.2	Diameter ≥ 17mm	27mm
6	Setting time test	EN ISO 6876: 2012 5.4	≤ 360 min	Within 360min
7	Film thickness test	EN ISO 6876: 2012 5.5	≤ 50 μm	30 μm
8	Radio-opacity test	EN ISO 6876: 2012 5.7	More than 3mm	4.6mm
9	Solubility test	EN ISO 6876: 2012 5.6	≤ 3%	0.2%

In addition, Biocompatibility testing was performed with the following acceptance criteria and evaluation:

No.	Test	Standard & Method	Acceptance criteria	Evaluation
1	Cytotoxicity	EN ISO 10993-5 Agar diffusion assay	Non cytotoxic (Scale 0)	Scale 0 (Non cytotoxic)
2	Oral mucosal irritation	EN ISO 10993-23	Irritation index 0	Irritation index 0
3	Skin Sensitization	EN ISO 10993-10 GPMT	Sensitization score and rate 0	Sensitization score and rate 0
4	Acute systemic toxicity	EN ISO 10993-11 Single dose	No Acute systemic toxicity	No Acute systemic toxicity
5	Systemic toxicity	EN ISO 10993-11 Pyrogen test	No abnormal signs and dead	No abnormal signs and dead
6	Genotoxicity	EN ISO 10993-3 Back mutation.	No back mutation regardless of the presence or absence of a metabolic activation system	No back mutation
		Chromosomal aberration	No chromosomal aberration in CHL/IU cells	No chromosomal aberration in CHL/IU cells
7	Implantation	EN ISO 10993-6 Implantation	Biocompatible	Biocompatible
8	Sub-chronic toxicity	EN ISO 10993-11 Subchronic toxicity	No Subchronic toxicity	No Subchronic toxicity
9	Chronic toxicity	EN ISO 10993-11 Chronic toxicity	No chronic toxicity	No chronic toxicity
10	Carcinogenicity	EN ISO 10993-3 Carcinogenicity	No Carcinogenicity	No Carcinogenicity

2. Sample size used for the test set and the data provenance

Sample Size: Not explicitly stated in terms of number of samples/units tested for each mechanical or biocompatibility test, but the tests were performed on the device itself.
Data Provenance: The document implies in-house testing performed by or for Genoss Co., Ltd. The country of origin for the company is South Korea. The studies are assumed to be prospective tests on newly manufactured samples of the device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable. This is not an AI device that requires expert-established ground truth for image interpretation or diagnosis. The ground truth for this device's performance is derived from standardized physical and biological material testing.

4. Adjudication method for the test set

Not Applicable. As this is not an AI device involving human interpretation, there is no need for an adjudication method for a test set. The results are based on objective measurements from standardized tests.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No. An MRMC study is relevant for AI systems that assist human readers in tasks like radiological interpretation. This device is a material, not an AI system, so an MRMC study would not be performed.

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

Not Applicable. This is not an algorithm or AI system. Its performance is inherent to its physical and chemical properties.

7. The type of ground truth used

The ground truth for this device's performance is based on objective measurements from internationally recognized standards (ISO and EN ISO) for dental materials and biocompatibility. For example, specific diameters for flow, time limits for setting, weight differences, and qualitative assessments of physical appearance and biological reactions are used as the "ground truth" against which the device's performance is measured. It's not expert consensus, pathology, or outcomes data in the traditional sense of diagnostic AI.

8. The sample size for the training set

Not Applicable. This is not an AI device that undergoes machine learning training.

9. How the ground truth for the training set was established

Not Applicable. As it's not an AI device, there is no training set or associated ground truth establishment process.

Summary

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July 28, 2023

Genoss Co., Ltd. Boram Choi Assistant Manager D-factory, 56, Changnyong-daero 256beon-gil, Yeongtong-gu Suwon-si. Gyeonggi-do 16229 SOUTH KOREA

Re: K231480

Trade/Device Name: Bright MTA Sealer Plus Regulatory Class: Class II Product Code: KIF Dated: April 5, 2023 Received: May 22, 2023

Dear Boram Choi:

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

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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 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 (QS) 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,

Michael E. Adjodha -S

Michael 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) K231480

Device Name Bright MTA Sealer Plus

Indications for Use (Describe) Bright MTA Sealer Plus is used for filling root canals

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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Image /page/3/Picture/0 description: The image shows the word "GENOSS" in a stylized font. The first three letters, "GEN", are in a dark green color. The last three letters, "OSS", are in a lighter green color.

510(k) Summary

02/05/2023

1. Company

	Submitter
Name	GENOSS Co., Ltd.
Address	Head office: 1F Gyeonggi R&DB center, 105 Gwanggyo-ro, Yeongtong-gu,Suwon-si, Gyeonggi-do, 16229, Republic of KoreaFactory: D-factory, 56, Changnyong-daero 256beon-gil, Yeongtong-gu,Suwon-si, Gyeonggi-do, 16256, Republic of Korea
Phone/Fax	+82-70-7098-6352/ +82-31-888-5595
Contact person	Boram Choi / RAbrchoi@genoss.com
Summary Date	02/05/2023

2. Device

Proprietary name:	Bright MTA Sealer Plus
Common Name:	Root filling material
Classification Name:	Root canal filling resin
Regulation Number:	21 CFR 872.3820
Product Code:	KIF
Regulatory Class:	Class II

3. Predicate Device

K170175 Endoseal MTA

4. Device Description

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Image /page/4/Picture/0 description: The image shows the word "GENOSS" in a stylized font. The first three letters, "GEN", are in a dark green color. The last three letters, "OSS", are in a lighter green color.

5. Indication for use

Bright MTA Sealer Plus is used for filling root canals.

6. Technological Characteristics

Bright MTA Sealer Plus was compared with the predicate device 'ENDOSEAL MTA' in clinical, technical, biological view. The characteristics that differed from the predicate device were performed by gap analysis, which confirmed equivalence with the predicate device. Technological characteristics of Bright MTA Sealer Plus and ENDOSEAL MTA are as following;

Device name		SUBJECT DEVICE	PREDICATED DEVICE
		Bright MTA Sealer Plus	Endoseal MTA(K170175)
	Manufacture	Genoss Co.,Ltd.	Maruchi
	Classification	Class II	Class II
	Product code	KIF	KIF
Clinical	Target population	Human tooth root canal	Human tooth root canal
	Purpose	Bright MTA Sealer Plus is used forfilling root canals.	Materials used for root canal filling
	Site of application	root canal	root canal
	ClinicalPerformance	Repair of root resorptionRoot-end-filling	Repair of root resorptionRoot-end-filling
	Principle ofoperation	Bright MTA Sealer Plus is an injectablepaste like material for root canal filling,which is hardened and obturated afterbeing injected into the root canal space.	Endoseal MTA is an endodontic sealerbased on MTA, providing a root canalfilling.
Technical	Solubility	0.2 %	0.7 %
	Flow test	27 mm	21 mm
	Setting time	Within 360 min	12.31 min
	Film Thickness	30 μm	15 μm
	Radio-opacity	4.6 mm	10.5 mm
B1010	Material	CaCO3, Al2O3, SiO2, NaHCO3(Calcium silicate)ZrO₂, Li₂Co₃, 1,3-Propandiol	CaCO3, Al2O3, SiO2, Fe2O3(Natural pure cement)ZrO₂, Bi₂O₃, Bentonite Clay

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	Polyethylene glycol,Polar acidic ester of long chainalcohols	N-Methyl-2-Pyrrolidone,Hypromellose
Chemical Safety	Biocompatible	Biocompatible
Sterile	Non sterile	Non sterile
Shelf-Life	2 years	2 years
Packaging	Pre-loaded syringe	Pre-loaded syringe
Duration of Contact	Permanent contact - contact exceeds30d	Permanent contact - contact exceeds30d

7. Performance Data

Biocompatibility testing

Biocompatibility testing on the proposed Bright MTA Sealer has been completed. Requirements for biological evaluation of the proposed device were based on FDA recognized concensus standard of ISO10993, "Biological Evaluation of Medical Devices, Part 1: Evaluation and Testing." The biocompatibility test results show that the materials used in the design and manufacture of the components of the proposed device are non-toxic and nonsensitizing to biological bone and tissues with its intended use. The following biocompatibility tests were completed:

No.	Test	Standard & Method	Acceptance criteria	Evaluation
1	Cytotoxicity	EN ISO 10993-5Agar diffusion assay	Non cytotoxic(Scale 0)	Scale 0(Non cytotoxic)
2	Oral mucosalirrittation	EN ISO 10993-23	Irritation index 0	Irritation index 0
3	Skin Sensitization	EN ISO 10993-10GPMT	Sensitization scoreand rate 0	Sensitization score andrate 0
4	Acute systemictoxicity	EN ISO 10993-11Single dose	No Acute systemictoxicity	No Acute systemictoxicity
5	Systemic toxicity	EN ISO 10993-11Pyrogen test	No abnormal signsand dead	No abnormal signs anddead
6	Genotoxicity	EN ISO 10993-3Back mutation.	No back mutationregardless of the	No back mutation

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		Chromosomalaberration	presence or absenceof a metabolicactivation system
			No chromosomalaberration inCHL/IU cells	No chromosomalaberration in CHL/IUcells
7	Implantation	EN ISO 10993-6Implantation	Biocompatible	Biocompatible
8	Sub-chronictoxicity	EN ISO 10993-11Subchronic toxicity	No Subchronictoxicity	No Subchronictoxicity
9	Chronic toxicity	EN ISO 10993-11Chronic toxicity	No chronic toxicity	No chronic toxicity
10	Carcinogenicity	EN ISO 10993-3Carcinogenicity	No Carcinogenicity	No Carcinogenicity

Mechanical testing

The proposed Bright MTA Sealer Plus was evaluated using the following performance bench testing to confirm the performance characteristics:

No.	Items	Standard &Method	Acceptance Criteria	Result
1	Visual test	ISO 4049Bare eyes	No alien substance andsuitable for using theproduct	No alien substance andsuitable for using theproduct
2	Capacity test	ISO 4049Weightdifference	Standard weight $\pm$ ±5%	1.50 %
3	Package test	ISO 4049Bare eyes	No damages, cracks	The package wascompletely sealed, andthere were no damages.cracks.
4	Extraneousmatter test	ISO 4049Bare eyes	No extraneous matter	No Extraneous Matter
5	Flow test	EN ISO 6876:2012 5.2	Diameter ≥ 17mm	27mm
6	Setting time test	EN ISO 6876:2012 5.4	≤ 360 min	Within 360min
7	Film thicknesstest	EN ISO 6876:2012 5.5	≤ 50 $\mu$ m	30 $\mu$ m
8	Radio-opacitytest	EN ISO 6876:2012 5.7	More than 3mm	4.6mm
9	Solubility test	EN ISO 6876:2012 5.6	≤ 3%	0.2%

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Image /page/7/Picture/0 description: The image shows the word "GENOSS" in a stylized font. The first three letters, "GEN", are in a dark green color, while the last three letters, "OSS", are in a lighter green color. The letters are connected, forming a single word.

All test results demonstrate that the materials chosen, the manufacturing process, and the design utilized for the Bright MTA Sealer Plus met the established specifications necessary for consistent performance according to its intended use.

8. Conclusion

Based on the information provided in this premarket notification of GENOSS Co., Ltd. concluded that Bright MTA Sealer Plus is acceptable and safe, substantially equivalent to predicate device.

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.