It is a 7th generation dentin adhesive system that handles all the functions of the conditioner primer bonding resin. The polymerization method is photopolymerization type, and after being applied to the tooth surface, the solvent is volatilized and polymerized in the drying process to perform the function as a dentine adhesive.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a dental resin bonding agent, DIAPLUS Universal (K213401). This submission aims to demonstrate substantial equivalence to a predicate device, ALL-BOND Universal w/BAC (K161051).

However, this document does not contain information about an AI-powered medical device or software that would have "acceptance criteria" related to AI performance metrics like accuracy, sensitivity, specificity, or the results of a multi-reader multi-case (MRMC) study.

Instead, the document focuses on demonstrating the substantial equivalence of a physical dental product (resin tooth bonding agent) through:

Comparison of Indications for Use, Composition, and Principle of Operation with a predicate device.
Non-clinical performance data which includes physical property tests (e.g., film thickness, shear bonding strength, sensitivity to light, occlusion of dentinal tubules) and biocompatibility tests (e.g., cytotoxicity, genotoxicity, irritation, systemic toxicity) conducted according to established international standards (ISO).
A statement that no clinical performance data was collected because it was not deemed necessary to demonstrate substantial equivalence for this type of device.

Therefore, it is not possible to answer the request based on the provided text, as the document does not describe an AI medical device or a study proving its performance against AI-specific acceptance criteria.

The questions in your prompt (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth, training set details) are relevant for AI/ML-based medical device submissions, but they do not apply to the traditional dental material device described in this specific FDA 510(k) clearance document.

Summary

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January 31, 2022

Diadent Group International Kab Lee Quality Assurance Manager 16, Osongsaengmyeong 4-ro, Osong-eup, Heungdeok-gu Cheongju-si, Chungcheongbuk-do 28161 SOUTH KOREA

Re: K213401

Trade/Device Name: DIAPLUS Universal Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: Class II Product Code: KLE Dated: August 29, 2021 Received: October 18, 2021

Dear Kab Lee:

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,

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) K213401

Device Name DIAPLUS Universal

Indications for Use (Describe)

1. All direct restorations
1. All indirect restorations
1. Desensitizing/sealing of tooth
1. Intra-oral repairs

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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K213401

510(k) Summary

1 Application Information

Date Prepared:	Jan 27, 2022
Company Name and Address:	DiaDent Group International16, Osongsaengmyeong 4-ro, Osong-eup, Heungdeok-gu, Cheongju-si, Chungcheongbuk-do, 28161, Republic of Korea
Contact Person:	Kab Sun, LeeQuality Assurance ManagerPhone: +82-43-266-2315FAX: +82-43-235-2315Email: diadent32@diadent.co.kr

2 Device Information

510(k) Number	K213401
Classification Name	Agent, Tooth Bonding, Resin
Common Name	Resin tooth bonding agent.
Review Panel:	Dental
Regulation Number:	21 CFR 872.3200
Product Code:	KLE
Device Class:	II
Trade Name	DIAPLUS Universal

3 Predicate Devices

The legally marketed devices to which substantial equivalence is being claimed are:

	Primary Predicate Device
510(k) Number:	K161051
Applicant:	BISCO, Inc.
Device Name:	All-Bond Universal w/BAC
Regulation Number:	21 CFR 872.3200
Product Code:	KLE
Device Class:	II

4 Device Configuration

DIAPLUS Universal: 1 bottle (5ml, 1ml)

5 Device Description

6 Intended Use/Indications for Use

1. All direct restorations
1. All indirect restorations
1. Desensitizing/sealing of tooth
1. Intra-oral repairs

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7 Comparison Table and Discussion

This device compares to the legally marketed devices as follows:

	Subject Device	Primary Predicate Device
Common name	Resin tooth bonding agent.	Resin tooth bonding agent.
Trade Name	DIAPLUS Universal	ALL-BOND Universal w/BAC	Discussion
510(k)Number	K213401	K161051	-
Indication forUse	1. All direct restorations2. All indirect restorations3. Desensitizing/sealing of tooth4. Intra-oral repairs	1. all direct restorations2. all indirect restorations3. intra-oral repairs (i.e. repair of anyfixed dental prosthesis containingzirconia, alumina, metals, glassceramics, toothstructure, and composites)4. desensitizing/sealing of toothstructure5. protective varnish for glass ionomerfillings6. priming of enamel for orthodonticuse	Equivalent
Composition	- 10-methacryloyloxydecyldihydrogenphosphate- 2-Hydroxyethyl methacrylate- Bis[2-(methacryloyloxy)ethyl]phosphate- 3-(Trimethoxysilyl)propylmethacrylate- Trimethylolpropanetrimethacrylate- BisGMA/TEGDMA MonomerBlend- Poly(ethylene glycol)dimethacrylate- Diphenyliodoniumhexafluorophosphate- Phenyl Bis(2,4,6-Trimethylbenzoyl)phosphineoxide- (+/-)Camphorquinone- Ethyl 4-dimethyl aminobenzoate- tert-butyl hydroquinone- Ethyl alcohol- Silicon dioxide	- 10-Methacryloyloxydecyl dihydrogenphosphate- 2-hydroxyethyl methacrylate- Bisphenol A diglycidylmethacrylate- water- ethanol
Principle ofoperation	After being applied to the toothsurface, the solvent is volatilizedand photopolymerized in thedrying process to perform thefunction as a dentin adhesive. Themain material, MDP contains ahydrophobic long carbon chainand a hydrophilic phosphategroup, so it has excellent surfaceactivity and can easily permeatesdentin & enamel. It increasesbonding to hydroxyapatiteremaining in dentin.	All-Bond Universal is anethanol/water-based dental adhesivewhich bonds to dentin and cut and un-cut enamel.	Equivalent
PerformanceStandardConformance	ConformedISO 4049 and ISO 29022	ConformedISO 4049 and ISO 29022	Equivalent
	Subject Device	Primary Predicate Device
Common name	Resin tooth bonding agent.	Resin tooth bonding agent.
Trade Name	DIAPLUS Universal	ALL-BOND Universal w/BAC	Discussion
Physicalproperties	- Film thickness- Sensitivity to light- Shear bond strength- Occlusion of dental tubules	- Film thickness- Shear bond strength	Equivalent
Biocompatibility	Biocompatible	Biocompatible	Equivalent
PackageContents	One bottle	One bottle	Equivalent
RX only/OTC	RX Only	RX Only	equivalent

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Differences

-Composition

Subject Device(DIAPLUS Universal)	Predicate Device(ALL-BOND Universal w/BAC)	Discussion
- 10-methacryloyloxydecyldihydrogen phosphate- 2-Hydroxyethyl methacrylate- Bis[2-(methacryloyloxy)ethyl]phosphate- 3-(Trimethoxysilyl)propylmethacrylate- Trimethylolpropanetrimethacrylate- BisGMA/TEGDMA MonomerBlend- Poly(ethylene glycol)dimethacrylate- Diphenyliodoniumhexafluorophosphate- Phenyl Bis(2,4,6-Trimethylbenzoyl)phosphineoxide- (+/-) Camphor quinone- Ethyl 4-dimethyl aminobenzoate- tert-butyl hydroquinone- Ethyl alcohol- Silicon dioxide	- 10-Methacryloyloxydecyldihydrogen phosphate- 2-hydroxyethyl methacrylate- Bisphenol Adiglycidylmethacrylate- water- ethanol	The main ingredients (10-methacryloyloxydecyl dihydrogenphosphate, 2-Hydroxyethyl methacrylate)are similar, with some different ingredients.However, the results of biocompatibilityand performance tests confirm thatDIAPLUS Universal similar products areequivalent. Performance tests confirm thatDIAPLUS Universal similar products areequivalent.

8. Non-Clinical performance data

This device has demonstrated conformance with non-clinical performance requirements through evaluation and testing in accordance with the following harmonized standards:

-ISO 4049	Dentistry -- Polymer-based restorative materials
-ISO 7405	Dentistry - Evaluation of Biocompatibility of Medical Devices Used In Dentistry[Including: Amendment 1 (2013)]
-ISO 29022	Dentistry - Adhesive - Notched-edge sheer bond strength test
-ISO 10993-1	Biological evaluation of medical devices - Part 1: Evaluation and testing within arisk management process
-ISO 10993-3	Biological evaluation of medical devices - Part 3: Tests for genotoxicitycarcinogenicity and reproductive toxicity

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-ISO 10993-5	Biological evaluation of medical devices - Part 5: Tests for in vitro Cytotoxicity
-ISO 10993-10	Biological evaluation of medical devices - Part 10: Tests for irritation and skinsensitization
-ISO 10993-11	Biological evaluation of medical devices - Part 11: Tests for Systemic toxicity

The following Performance tests were conducted.

Film Thickness
Shear Bonding Strength
Sensitivity to Ambient Light
Occlusion of dentinal tubules

Biocompatibility test:

Test	Standard	Test result
Cytotoxicity Study	• 10993-5 - Biological Evaluation of Medical Devices -Part 5: Tests for In Vitro Cytotoxicity	NotCompatibleBSE
Bacterial Reverse Mutation Study	• 10993-3 - Biological Evaluation of Medical Devices –Part 3: Tests for genotoxicity, carcinogenicity andreproductive toxicity	Compatible
In vitro Mammalian Chromosomal Aberration Test	• 10993-3 - Biological Evaluation of Medical Devices -Part 3: Tests for genotoxicity, carcinogenicity andreproductive toxicity	Compatible
Mammalian Erythrocyte Micronucleus	• 10993-3 - Biological Evaluation of Medical Devices -Part 3: Tests for genotoxicity, carcinogenicity andreproductive toxicity	Compatible
Skin Sensitization Test	• 10993-10 - Biological Evaluation of Medical Devices -Part 10: Tests for Irritation and Skin Sensitization	Compatible
Oral Mucosa Irritation Test	• 10993-10 - Biological Evaluation of Medical Devices -Part 10: Tests for Irritation and Skin Sensitization	Compatible
Acute Systemic Toxicity	• 10993-11 - Biological Evaluation of Medical Devices -Part 11: Tests for Systemic Toxicity	Compatible

(Among the components of this product, 10-MDP is an acidic monomer, and depending on the acidity, it is a substance that causes cytotoxicity according to the principle of action of this product, so cytotoxicity test setting the test item is meaningless.

9 Clinical Performance Data

No clinical data was collected or provided to support substantial equivalence between the subject and predicate devices.

10. Conclusion

Based on the above information and all data provided in this submission, the comparison of intended uses, technological characteristics, and non-clinical performance testing demonstrates that the subject device is substantially equivalent to the legally marketed devices identified in this submission.

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Regulation Number and Section

§ 872.3200 Resin tooth bonding agent.

(a)
Identification. A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.(b)
Classification. Class II.