Bright Flow is a light-cured flowable composite resin. It comprises two different types of flowability (Low Flow and High Flow) and 9 shades depending on the intended use, which enables aesthetic and durable outcomes for anterior and posterior composite restorations.

AI/ML Overview

This document is a 510(k) summary for the medical device "Bright Low Flow", a light-cured flowable composite resin manufactured by GENOSS Co., Ltd. It declares that the device is substantially equivalent to a predicate device (K091388 G-aenial Universal Flo) and provides performance data to support this claim.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document presents two tables related to performance criteria: Biocompatibility and Performance Bench Testing.

Biocompatibility Acceptance Criteria and Performance:

No.	Test	Method	Acceptance criteria	P/F (Result)
1	Cytotoxicity	ISO 10993-5	None cytotoxicity	Pass
2	Irritation	ISO 10993-10	None oral irritation	Pass
3	Sensitization	ISO 10993-10	None sensitization	Pass
4	Acute systemic toxicity	ISO 10993-11	None systemic toxicity	Pass
5	Genotoxicity	ISO 10993-3	None genotoxicity	Pass
6	Implantation	ISO 10993-6	Biocompatible	Pass
7	Chronic toxicity	ISO 10993-11	No chronic toxicity	Pass

Performance Bench Testing Acceptance Criteria and Performance:

No.	Items	Method	Acceptance Criteria	Result
1	Visual	ISO 4049	No impurities and No specific changes	No impurities and No specific changes
2	Capacity	ISO 4049	Capacity error of; Standard Capacity < ±5%	Size error of; Standard Size < ±5% H 0.43%, Ø 0.03%
3	Package	ISO 4049	No damage	No damage
4	Sensitivity to Ambient Light	ISO 4049	Must be physically uniform	Uniformity
5	Depth of Cure	ISO 4049	More than 1.5 mm	Average: 2.9 mm
6	Shade	ISO 4049	Must be shade uniform	Uniformity
7	Color Stability	ISO 4049	Color should be stable	Stable
8	Flexural Strength	ISO 4049	More than 80 MPa	Average: 142 MPa
9	Water Sorption	ISO 4049	Less than 40 µg/mm3	Average: 23 µg/mm3
10	Solubility	ISO 4049	Less than 7.5 µg/mm3	Average: 0.9 µg/mm3
11	Radio-opacity	ISO 4049	More than Al	≥ Al (1.81)

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

The document does not explicitly state the sample sizes used for each of the biocompatibility and performance bench tests. However, the tests are identified by their ISO standard methods (e.g., ISO 10993-5, ISO 4049), implying that the testing was conducted according to these internationally recognized standards, which typically define appropriate sample sizes.

Data Provenance: The document indicates that the submitter is "GENOSS Co., Ltd." located in "Suwon-si, Gyeonggi-do, Korea." This suggests the data was generated in South Korea, or at least commissioned by a South Korean company. The tests are referred to as "Biocompatibility testing on the proposed Bright Low Flow has been completed" and "The proposed Bright Low Flow was evaluated using the following performance bench testing," implying these are prospective tests performed on the device itself for this submission.

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

This information is not provided in the document. The tests performed are laboratory-based physical and chemical property evaluations or biological assays (biocompatibility) rather than interpretations requiring human expert consensus on a test set.

4. Adjudication Method for the Test Set

This information is not applicable as the tests are objective, laboratory-based measurements or biological assays, not interpretations requiring adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable. The device is a "light-cured flowable composite resin" (dental material), not an AI diagnostic or assistive tool.

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

This information is not applicable. The device is a dental material, not an algorithm.

7. The Type of Ground Truth Used

For the biocompatibility tests, the "ground truth" is based on the biological response observed in the specific assays according to the ISO 10993 standards (e.g., cell viability for cytotoxicity, skin reaction for irritation, systemic effects for acute systemic toxicity).

For the performance bench tests, the "ground truth" is the quantitative measurement of the physical/chemical properties of the material (e.g., depth of cure in mm, flexural strength in MPa, water sorption in µg/mm3) as determined by the specified ISO 4049 standard methods. This represents direct measurement of inherent material properties.

8. The Sample Size for the Training Set

This information is not applicable. As a dental material, there is no "training set" in the context of machine learning or AI models. The device's properties are inherent to its formulation and manufacturing process, evaluated through scientific testing.

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

This information is not applicable for the reasons stated in point 8.

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 & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 27, 2020

Genoss co.,Ltd. Hong Jeon Manager 1F, Gyeonggi R&DB Center, 105 Gwanggyo-ro, Yeongtong-gu, Suwon-si Suwon-si, Gyeonggi-do 16229 South Korea

Re: K200156

Trade/Device Name: Bright Low Flow Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth shade resin material Regulatory Class: Class II Product Code: EBF Dated: August 3, 2020 Received: August 3, 2020

Dear Hong Jeon:

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

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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 Srinivas "Nandu" Nandkumar, Ph.D. Director DHT1B: Division of Dental 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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Indication for use

510(k) Number: K200156

Device Name: Bright Low Flow

Indication for use:

Class I, III, V (non-stress area, minimally invasive restoration)
Composite resin repair

Prescription Use _ √ _ (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Indication for use

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Image /page/3/Picture/0 description: The image shows the logo for GENOSS. The logo is in green and features the word "GENOSS" in a stylized font. The first four letters, "GENO", are in a darker green, while the last two letters, "SS", are in a lighter green. The logo has a modern and clean design.

510(k) Summary K200156

12/20/2019

1. Company

	Submitter
Name	GENOSS Co., Ltd.
Address	1F, Gyeonggi R&DB Center / 226, 2F, GSBC, 105Gwanggyo-ro, Yeongtong-gu, Suwon-si, Gyeonggi-do, Korea
Phone/Fax	+82-70-7098-7541/ +82-31-888-5105
Contact person	HongJun Jeon / RAhjjeon@genoss.com
Summary Date	12/20/2019

2. Device Name

Proprietary name: Bright Low Flow Regulation description : Light-cured Flowable Composite Resin Classification name: Tooth shade resin material

3. Predicate Device

K091388 G-aenial Universal Flo

4. Description

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Image /page/4/Picture/0 description: The image shows the word "GENOSS" in a stylized font. The first four letters, "GENO", are in a dark green color, while the last two letters, "SS", are in a lighter, lime green color. The letters are connected, giving the word a flowing appearance.

5. Indication for use

1. Class I, III, V (non-stress area, minimally invasive restoration)
1. Composite resin repair

6. Technological Characteristics

Bright Low Flow has the similar technological characteristics as the predicate device; main material, indication for use and design. Technological characteristics of Bright Low Flow, Gaenial Universal Flo are as following.

Device name	Bright Low Flow	G-aenial Universal Flo
Manufacturer	Genoss Co., Ltd.	GC America, Inc.
510(k) Number	New Device	K091388
Clinical	Target population	Human tooth	Human tooth
	Purpose	Direct restoration	Direct restoration
	Site of application	Dentin, Enamel	Dentin, Enamel
	Clinical Performance	High flexural strength and strong bonding	High flexural strength and strong bonding
Biological	Materials	Methacrylate resins, Fillers (Barium glass, Silica)	Methacrylate resins, Fillers (Barium glass, Silica)
	Chemical Safety	Biocompatible	Biocompatible
	Sterilization	Non-sterile	Non-sterile
	Shelf-Life	2 years	3 years
Technical	Form	Paste	Paste
	Indication for use	1) Class I, II, III, V (non-stress area, minimally invasive restoration)2) Composite resin repair	1) Direct restorative for Class I, IV, III, II and V cavities.2) Fissure sealant3) Sealing hypersensitive areas4) Repair of (in) direct aesthetic restorations, temporary crown &

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		bridge, defect margins when marginsare in enamel5) Blocking out undercuts6) Liner or base
Use	Prescription	Prescription
Depth of cure	2.9 mm	2.8 mm
Water Sorption	23 $\mu g/mm^3$	Less than 40 $\mu g/mm^3$
Solubility	0.9 $\mu g/mm^3$	Less than 7.5 $\mu g/mm^3$
Flexural Strength	142 Mpa	167 Mpa
Radio-opacity	1.81	More than Aluminum

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Image /page/6/Picture/0 description: The image shows the word "GENOSS" in a stylized font. The letters "GEN" are in a dark green color, while the letters "OSS" are in a lighter, lime green color. The font is bold and slightly rounded, giving the word a modern and professional appearance.

7. Performance Data

Biocompatibility testing on the proposed Bright Low Flow 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 non-sensitizing to biological bone and tissues with its intended use. The following biocompatibility tests were completed:

(P: Pass, F: Fail)

No.	Test	Method	Acceptance criteria	P/F	Report No.
1	Cytotoxicity	ISO 10993-5	None cytotoxicity	P	CDM-18-0057-12
2	Irritation	ISO 10993-10	None oral irritation	P	MTK-2018-000704
3	Sensitization	ISO 10993-10	None sensitization	P	MTK-2018-000703
4	Acute systemic toxicity	ISO 10993-11	None systemictoxicity	P	MTK-2018-000703
5	Genotoxocity	ISO 10993-3	None genotoxicity	P	MTK-2018-000702
6	Implantation	ISO 10993-6	Biocompatible	P	BER-18-027
7	Chronic toxicity	ISO 10993-11	No chronic toxicity	P	BER-18-027

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GENO

The proposed Bright Low Flow was evaluated using the following performance bench testing to confirm the performance characteristics:

No.	Items	Method	AcceptanceCriteria	Result	File No.
1	Visual	ISO 4049	No impuritiesand No specificchanges	No impuritiesand No specificchanges	CDM-18-0057-01
2	Capacity	ISO 4049	Capacity error of;Standard Capacity <±5%	Size error of;Standard Size < ±5%H 0.43%, Ø 0.03%	CDM-18-0057-02
3	Package	ISO 4049	No damage	No damage	CDM-18-0057-03
4	Sensitivity toAmbient Light	ISO 4049	Must bephysically uniform	Uniformity	CDM-18-0057-04
5	Depth of Cure	ISO 4049	More than 1.5 mm	Average: 2.9 mm	CDM-18-0057-05
6	Shade	ISO 4049	Must be shadeuniform	Uniformity	CDM-18-0057-06
7	Color Stability	ISO 4049	Color should bestable	Stable	CDM-18-0057-07
8	FlexuralStrength	ISO 4049	More than 80 MPa	Average: 142 MPa	CDM-18-0057-08
9	Water Sorption	ISO 4049	Less than 40 µg/mm3	Average: 23 µg/mm3	CDM-18-0057-09
10	Solubility	ISO 4049	Less than 7.5 µg/mm3	Average: 0.9 µg/mm3	CDM-18-0057-10
11	Radio-opacity	ISO 4049	More than Al	≥ Al (1.81)	CDM-18-0057-11

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

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Image /page/8/Picture/0 description: The image shows the word "GENOSS" in a stylized font. The letters "GENO" are in a dark green color, while the letters "SS" are in a lighter green color. The font is bold and slightly italicized, giving the word a dynamic appearance.

8. Conclusion

Based on the information provided in this premarket notification of GENOSS Co., Ltd. Concludes that Bright Low Flow is acceptable and safe, substantially equivalent to predicate devices.

Regulation Number and Section

§ 872.3690 Tooth shade resin material.

(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.