Dia-X Bond Universal is a universal adhesive capable of total, self, and selective etching as it consists of a single bottle of etching, primer, and adhesive resin. It can be used for both direct bonding of restorations.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a dental bonding agent named "Dia-X Bond Universal." The application focuses on demonstrating substantial equivalence to a predicate device, DIAPLUS Universal, rather than conducting a full clinical study with specific acceptance criteria in the typical sense of a medical diagnostic device.

Therefore, the information requested about acceptance criteria, study design for proving they are met, sample sizes, expert involvement, and ground truth establishment, does not directly apply in the same way as it would for a medical diagnostic device with performance metrics like sensitivity, specificity, or FROC scores.

The "acceptance criteria" here are more about demonstrating that the new device meets established standards and is functionally similar and safe compared to an already approved device. The "study" is a collection of non-clinical tests to show this equivalence.

Here's an attempt to answer your questions based on the provided document, interpreting "acceptance criteria" as compliance with relevant standards and "study" as the non-clinical performance data and biocompatibility tests:

1. A table of acceptance criteria and the reported device performance

For this premarket notification, the acceptance criteria are primarily defined by adherence to harmonized international standards for dental materials and demonstration of comparable physical properties and biocompatibility to the predicate device.

Acceptance Criteria Category	Specific Acceptance Criteria (Inferred from Standards & Comparat.)	Reported Device Performance (Summary from Non-Clinical Data)
Material Standards Compliance	Conformance to ISO 4049 (Polymer-based restorative materials)	Conformed
	Conformance to ISO 29022 (Adhesive - Notched-edge shear bond strength)	Conformed
Biocompatibility Standards Compliance	Conformance to ISO 7405 (Evaluation of Biocompatibility of Medical Devices in Dentistry)	Conformed
	Conformance to ISO 10993-1, 3, 5, 10, 11 (Biological evaluation)	Most tests were "Compatible," with an explanation for "Not Compatible" in cytotoxicity.
Physical Properties	Similar Film Thickness to predicate	Performed (Result not explicitly quantified as 'value met')
	Similar Sensitivity to Light to predicate	Performed (Result not explicitly quantified as 'value met')
	Similar Shear Bond Strength to predicate	Performed (Result not explicitly quantified as 'value met')
	Similar Occlusion of Dental Tubules to predicate	Performed (Result not explicitly quantified as 'value met')
Chemical Composition	Same composition as predicate device	Equivalent (As per comparison table)
Indication for Use	Same indications as predicate device	Equivalent (As per comparison table)
Principle of Operation	Same principle of operation as predicate device	Equivalent (As per comparison table)

Note on "Cytotoxicity Study": The table states "Not Compatible BSE" for the Cytotoxicity Study but provides an explanation: "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." This essentially argues that for this specific type of dental adhesive, some level of cytotoxicity is inherent to its mechanism of action and is considered acceptable within the context of its intended use and formulation.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify sample sizes for the individual non-clinical performance tests (Film Thickness, Shear Bonding Strength, Sensitivity to Ambient Light, Occlusion of dentinal tubules) or for the biocompatibility tests beyond listing the tests themselves.

The data provenance is implicit: the tests were conducted by Diadent Group International, a company based in South Korea. The tests are non-clinical, likely laboratory-based, and would be considered prospective in the sense that they were performed specifically for this submission, but not in the clinical trial sense.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This question is not applicable to this type of device submission. There was no "test set" in the context of expert review for diagnostic accuracy, nor was there a concept of "ground truth" established by experts in this manner. The studies conducted were laboratory-based physical and biological tests against established standards, not expert-adjudicated clinical cases.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This question is not applicable. There was no expert adjudication process for a test set, as the evaluation relied on laboratory measurements and adherence to international standards.

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 question is not applicable. The device is a resin tooth bonding agent, not an AI-powered diagnostic tool. Therefore, no MRMC study or evaluation of human reader improvement with AI assistance was conducted or relevant.

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

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

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" in this context refers to the established scientific and technical standards for dental materials, specifically:

ISO 4049: Dentistry -- Polymer-based restorative materials
ISO 29022: Dentistry -- Adhesive -- Notched-edge shear bond strength test
ISO 7405: Dentistry - Evaluation of Biocompatibility of Medical Devices Used In Dentistry
ISO 10993 series: Biological evaluation of medical devices (Parts 1, 3, 5, 10, 11)

The "ground truth" for the comparative physical properties was the performance of the legally marketed predicate device (DIAPLUS Universal), implying that its performance established an acceptable benchmark.

8. The sample size for the training set

This question is not applicable. There is no "training set" in the context of a dental bonding agent, as it is a material, not a machine learning model.

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

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

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is in blue and consists of the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION".

June 15, 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: K220804

Trade/Device Name: Dia-X Bond Universal Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: Class II Product Code: KLE Dated: May 11, 2022 Received: May 16, 2022

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

{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,

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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K220804

Device Name Dia-X Bond Universal

Indications for Use (Describe)

All direct restorations
All indirect restorations
Desensitizing/sealing of tooth
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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Diadent Group International

Special 510(k) Summary

1 Application Information

Date Prepared:	May 11, 2022
Company Name andAddress:	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	K220804
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	Dia-X Bond Universal

3 Predicate Devices

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

	Primary Predicate Device
510(k) Number:	K213401
Applicant:	DiaDent Group International
Device Name:	DIAPLUS Universal
Regulation Number:	21 CFR 872.3200
Product Code:	KLE
Device Class:	II

4 Device Configuration

Dia-X Bond Universal: 1 bottle (5ml, 1ml)

5 Device Description

6 Intended Use/Indications for Use

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

{4}------------------------------------------------

Diadent Group International

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	Dia-X Bond Universal	DIAPLUS Universal	Discussion
510(k)Number	K220804	K213401
Indication forUse	- All direct restorations- All indirect restorations- Desensitizing/sealing of tooth- Intra-oral repairs	- All direct restorations- All indirect restorations- Desensitizing/sealing of tooth- Intra-oral repairs	Equivalent
Composition	- 10-methacryloyloxydecyldihydrogenphosphate- 2-Hydroxyethyl methacryalate- Bis[2-(methacryloyloxy)ethyl]phosphate- 3-(Trimethoxysilyl)propylmethacrylate- Trimethylolpropane trimethacrylate- BisGMA/TEGDMA Monomer Blend- 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-methacryloyloxydecyldihydrogenphosphate- 2-Hydroxyethyl methacryalate- Bis[2-(methacryloyloxy)ethyl]phosphate- 3-(Trimethoxysilyl)propylmethacrylate- Trimethylolpropane trimethacrylate- BisGMA/TEGDMA Monomer Blend- Poly(ethylene glycol) dimethacrylate- Diphenyliodoniumhexafluorophosphate- Phenyl Bis(2,4,6-Trimethylbenzoyl)phosphineoxide- (+/-)Camphorquinone- Ethyl 4-dimethyl aminobenzoate- tert-butyl hydroquinone- Ethyl alcohol- Silicon dioxide	Equivalent
Principle ofoperation	After being applied to the toothsurface, the solvent is volatilized andphotopolymerized in the dryingprocess to perform the function as adentin adhesive. The main material,MDP contains a hydrophobic longcarbon chain and a hydrophilicphosphate group, so it has excellentsurface activity and can easilypermeates dentin & enamel. Itincreases bonding to hydroxyapatiteremaining in dentin.	After being applied to the toothsurface, the solvent is volatilized andphotopolymerized in the dryingprocess to perform the function as adentin adhesive. The main material,MDP contains a hydrophobic longcarbon chain and a hydrophilicphosphate group, so it has excellentsurface activity and can easilypermeates dentin & enamel. Itincreases bonding to hydroxyapatiteremaining in dentin.	Equivalent
PerformanceStandardConformance	ConformedISO 4049 and ISO 29022	ConformedISO 4049 and ISO 29022	Equivalent
Physicalproperties	- Film thickness- Sensitivity to light- Shear bond strength- Occlusion of dental tubules	- Film thickness- Sensitivity to light- Shear bond strength- Occlusion of dental tubules	Equivalent
Biocompatibility	Biocompatible	Biocompatible	Equivalent
PackageContents	One bottle	One bottle	Equivalent
RX only/OTC	RX Only	RX Only	Equivalent

{5}------------------------------------------------

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
-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 ReverseMutation Study	•10993-3 - Biological Evaluation of Medical Devices -Part 3: Tests for genotoxicity, carcinogenicity andreproductive toxicity	Compatible
In vitro MammalianChromosomalAberration Test	•10993-3 - Biological Evaluation of Medical Devices -Part 3: Tests for genotoxicity, carcinogenicity andreproductive toxicity	Compatible
MammalianErythrocyteMicronucleus	•10993-3 - Biological Evaluation of Medical Devices -Part 3: Tests for genotoxicity, carcinogenicity andreproductive toxicity	Compatible
Skin SensitizationTest	•10993-10 - Biological Evaluation of Medical Devices -Part 10: Tests for Irritation and Skin Sensitization	Compatible
Oral MucosaIrritation Test	•10993-10 - Biological Evaluation of Medical Devices -Part 10: Tests for Irritation and Skin Sensitization	Compatible
Acute SystemicToxicity	•10993-11 - Biological Evaluation of Medical Devices -Part 11: Tests for Systemic Toxicity	Compatible

{6}------------------------------------------------

Diadent Group International

(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.

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.