DiaTemp is a temporary filling material that sets with curing light. In case the cavity is not permanently restored, Diatemp can be used as a temporary restoration until the next appointment. DiaTemp has four models and packaged with syringe and protective cap.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device called "DiaTemp," which is a temporary crown and bridge resin. The document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study report with acceptance criteria and performance metrics typically seen in AI/ML device submissions.

Therefore, many of the requested elements for describing "the acceptance criteria and the study that proves the device meets the acceptance criteria" are not applicable to this type of submission. This document pertains to a physical material, not an AI/ML diagnostic or prognostic algorithm.

Here's a breakdown based on the information available in the document:

1. Table of acceptance criteria and the reported device performance:

Since this is a physical material cleared through substantial equivalence, the "acceptance criteria" are typically defined by harmonized standards (e.g., ISO standards) and comparison to a predicate device. Performance is assessed through non-clinical testing rather than complex statistical metrics for diagnostic accuracy.

Acceptance Criterion (Implicit)	Reported Device Performance (DiaTemp)	Basis for Equivalence
Indications for Use: Temporary fillings, temporary protection in inlay and onlay technique (Equivalent to predicate).	All types of temporary fillings, temporary protection in inlay and onlay technique.	Equivalent to predicate (EVADYNE TEMPORARY CROWN AND BRIDGE RESIN) which is indicated for temporary restoration of crowns, bridges, or similar dental prostheses.
Description: Temporary filling material that sets with curing light, removable in one piece (Equivalent to predicate).	Temporary filling material that sets with curing light. Can be used as a temporary restoration until the next appointment.	Equivalent to predicate (EVADYNE) which is a light-cured temporary restoration material that can be removed in one piece.
Composition: Main ingredients are similar to predicate.	-Ethyl 4-(N,N-dimethylamino) benzoate-Silica amorphous,fumed-Urethane acrylate-BHT-Camphorquinone	Main ingredients are similar to predicate (EVADYNE: Ethyl-4-dimethylamino benzoate, Fluoroaluminosilicate glass, Polyester urethane dimethacrylat). Bio-compatibility and performance tests demonstrate substantial equivalence despite slight compositional differences.
Performance Standard Conformance: ISO 4049:2009 (Dentistry Polymer-based restorative materials)	Conforms to ISO 4049:2009	Equivalent to predicate.
Physical and Mechanical Properties:
- Sensitivity to ambient light: Homogeneous	Homogeneous	Equivalent to predicate.
- Depth of cure: > 1.5mm (Predicate: 2.5mm)	More than 1.5mm (average: 2.9 mm)	Comparable to predicate (2.5 mm).
- Curing Time: 20-30 seconds (Predicate: 20 seconds)	20 ~ 30 seconds	Comparable to predicate (20 seconds).
- Water sorption and solubility: (Implicit from ISO 4049)	Evaluated per ISO 4049	Not explicitly detailed, but conformity to ISO 4049 ensures these properties meet the standard.
- Shade & Colour stability: (Implicit from ISO 4049)	Evaluated per ISO 4049	Not explicitly detailed, but conformity to ISO 4049 ensures these properties meet the standard.
Period of Use: Prolonged exposure (exceed 24 hours but not 30 days)	Prolonged exposure (exceed 24 hours but not 30 days)	Equivalent to predicate.
Biocompatibility: Biocompatible, conforming to ISO 7405 and ISO 10993 standards.	Biocompatible (per ISO 7405, ISO 10993-1, -2, -3, -5, -6, -10, -11, -12)	Equivalent to predicate. Tests include genotoxicity, carcinogenicity, reproductive toxicity, cytotoxicity, local effects after implantation, irritation, skin sensitization, and systemic toxicity.
Use: Prescription/Hospital	Prescription/Hospital	Equivalent to predicate.

Regarding the specific questions that largely pertain to AI/ML studies:

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

Not applicable. This submission does not involve a "test set" in the context of an AI/ML algorithm. Performance was assessed through laboratory non-clinical testing of the material itself according to harmonized standards.

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):

Not applicable. Ground truth for an AI/ML algorithm is not relevant here. The "ground truth" for a material device like DiaTemp is established by the validated methods of the ISO standards themselves.

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

Not applicable. No adjudication method for a test set of data is described as this is not an AI/ML device.

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:

Not applicable. There was no MRMC study as this is not an AI-assisted diagnostic device.

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

Not applicable. There is no algorithm discussed.

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

For material properties: The "ground truth" is defined by the validated measurement methods and specified criteria within the harmonized ISO standards themselves (e.g., ISO 4049 for polymer-based restorative materials, ISO 7405 and ISO 10993 series for biocompatibility). These standards dictate how to objectively measure characteristics like depth of cure, water sorption, cytotoxicity, etc.

8. The sample size for the training set:

Not applicable. There is no "training set" as this is not an AI/ML device.

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

Not applicable. There is no "training set" or associated ground truth for an AI/ML algorithm described in this document.

Summary

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Image /page/0/Picture/0 description: The image shows 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 in blue. Underneath the FDA logo is the word "ADMINISTRATION".

February 13, 2020

Diadent Group International Kab Lee Quality Assurance Manager 16, Osongsaengmyeong 4-ro, Osong-eup, Heungdeok-gu Cheongji-si, 28161 Kr

Re: K192158

Trade/Device Name: DiaTemp Regulation Number: 21 CFR 872.3770 Regulation Name: Temporary Crown And Bridge Resin Regulatory Class: Class II Product Code: EBG Dated: October 1, 2020 Received: October 1, 2020

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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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,

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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Indications for Use

510(k) Number (if known) K192158

Device Name DiaTemp

Indications for Use (Describe)

All types of temporary fillings, temporary protection in inlay and onlay technique.

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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5.0 510(k) Summary

5.1 Application Information

Date Prepared	February 11, 2020
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

5.2 Device Information

Device Type	Material, Tooth Shade, Resin
Regulation Description	Tooth shade resin material.
Review Panel	Dental
Regulation Number	21 CFR 872.3690
Product Code	EBF
Device Class	II
Device Name	DiaTemp

5.3 Predicate Devices

The legally marketed device to which substantial equivalence is being claimed is:

510(k) Number	K111666
Applicant	NEO DENTAL CHEMICAL PRODUCTS CO., LTD.
Device Name	EVADYNE TEMPORARY CROWN AND BRIDGE RESIN
Regulation Number	21 CFR 872.3770
Product Code	EBG
Device Class	II

5.4 Device Description

Model Name	Color	Weight
DiaTemp Yellow 3g	Yellow	3g
DiaTemp Blue 3g	Blue	3g
DiaTemp Yellow Intro kit 1g	Yellow	1g
DiaTemp Blue Intro kit 1g	Blue	1g

5.5 Indications for Use

All types of temporary fillings, temporary protection in inlay and onlay technique.

5.6 Clinical Performance Data

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

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Product Name: DiaTemp

5.7 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 4049:2009, Dentistry Polymer-based restorative materials ●
ISO 7405:2009, Dentistry Evaluation of biocompatibility of medical devices used in dentistry ●
ISO 10993-1:2009, Evaluation and testing within a risk management process
ISO 10993-2:2006, Animal welfare requirements
ISO 10993-3:2014, Tests for genotoxicity, carcinogenicity and reproductive toxicity
. ISO 10993-5:2009, Tests for in vitro cytotoxicity
. ISO 10993-6:2016, Tests for local effects after implantation
ISO 10993-10:2010, Tests for irritation and skin sensitization
ISO 10993-11:2017, Tests for systemic toxicity
ISO 10993-12:2012, Sample preparation and reference materials

5.8 Technological Characteristics

The technological comparison of the subject device to the predicate device is as follows.

	Subject Device	Primary Predicate Device	Discuss
510(k)Number		K111666
Device code	EBF	EBG
Applicant	DiaDent GroupInternational	NEO DENTAL CHEMICALPRODUCTS CO., LTD.
Device Name	DiaTemp	EVADYNE TEMPORARYCROWN AND BRIDGERESIN
Indicationsfor Use	All types of temporaryfillings, temporaryprotection in inlay andonlay technique.	Evadyne is a light curedsingle-component materialfor the temporaryrestoration of crowns,bridges, or similar dentalprostheses. Evadyne isintended for the generaldental patientpopulation.	EquivalentThe indications for use ofthe subjective device andpredicate device is thetemporary filling, sealing,restoration.
Description	DiaTemp is a temporaryfillingmaterial that sets withcuring light.In case the cavity is notpermanently restored,DiaTempcan be used as atemporaryrestoration until the nextappointment.	Evadyne is a yellowishtranslucent, lowerviscosity, light-curedtemporary restorationmaterial for direct filling.After curing, Evadyne canbe removed in one piecewhen the permanentrestoration is to be placed.	Equivalent
PackageContents	-Syringe-Protective Cap	-Syringe-Disposable tips	Equivalent
Composition	-Ethyl 4-(N,N-dimethylamino)benzoate-Silica amorphous,fumed-Urethane acrylate-BHT-Camphorquinone	-Ethyl-4-dimethylaminobenzoate-Fluoroaluminosilicateglass-Polyester urethanedimethacrylat-	The main ingredients aresimilar. Also,biocompatibility andperformance testsdemonstrate that DiaTempand the predicate device

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DiaDent Group International

Product Name: DiaTemp

			are substantiallyequivalent.
PerformanceStandardConformance	ISO4049	ISO4049	Equivalent
Physical andMechanicalProperties	-Sensitivity to ambient light-Depth of cure-Curing time-Water sorption andsolubility-Shade & Colour stability	-Sensitivity to ambient light-Depth of cure-Curing time	Equivalent
Period of Use	Prolonged exposure(B)(exceed 24 hours but not30 days)	Prolonged exposure(B)(exceed 24 hours but not30 days)	Equivalent
Bio-compatibility	Biocompatible	Biocompatible	Equivalent
Use	Prescription/Hospital	Prescription/Hospital	Equivalent
Standards	ISO7405	ISO7405	Equivalent

There are similarities between the subject device and predicate device.

The indications for use of the subject device and predicate device is the temporary filling, sealing and restoration. Also, the subject device has similar physical properties to the predicate device.

Physical characteristics	Subject Device	Predicate Device
Sensitivity to ambient light	homogeneous	homogeneous
Depth of cure	More than 1.5mm(average: 2.9 mm)	2.5 mm
Curing Time	20 ~ 30 seconds	20 seconds

However, the composition of the subject device is slightly different from the predicate device. However, the main ingredients are similar. Also, the biocompatibility and performance tests were confirmed.

5.9 Conclusions

Based on the above information and all data provided in this submission, the subject device is substantially equivalent to the legally marketed devices identified in this submission.

Regulation Number and Section

§ 872.3770 Temporary crown and bridge resin.

(a)
Identification. A temporary crown and bridge resin is a device composed of a material, such as polymethylmethacrylate, intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.(b)
Classification. Class II.