The provided document describes the DIA-PROSEAL root canal filling resin and its substantial equivalence to a predicate device, AH Plus Root Canal Sealer. The focus is on non-clinical performance and there is explicitly no clinical performance data.

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

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

The document details the conformance of DIA-PROSEAL with ISO 6876:2012 (Dentistry — Root canal sealing materials). This standard sets the acceptance criteria for root canal sealing materials. The device's reported performance is its conformance to these tests, implying that the results obtained for DIA-PROSEAL met the specifications outlined in ISO 6876:2012.

Acceptance Criteria (from ISO 6876:2012)	Reported Device Performance (DIA-PROSEAL)
Setting time	Conforms
Film Thickness	Conforms
Radio-opacity	Conforms
Solubility	Conforms
Flow	Conforms

Additionally, the device demonstrates conformance to biocompatibility standards: ISO 7405:2008, ISO 10993-1:2009, ISO 10993-3:2014, ISO 10993-5:2009, ISO 10993-10:2010, and ISO 10993-11:2017. Specific biocompatibility tests performed include:

Biocompatibility Test (from ISO 10993 series)	Reported Device Performance (DIA-PROSEAL)
Bacterial Reverse mutation (Genotoxicity)	Conforms
Cytotoxicity	Conforms
Sensitization	Conforms
Irritation/Intracutaneous reactivity	Conforms
Acute systemic toxicity	Conforms

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 the sample size for the non-clinical tests (e.g., number of samples tested for setting time, film thickness, etc.). It only states that the device "demonstrated conformance" with the listed standards. There is no information regarding the country of origin of the data or whether the tests were retrospective or prospective.

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 information is not applicable to the provided document. The ground truth for this medical device is established through compliance with international standards for material properties and biocompatibility, not expert consensus on anatomical images or clinical outcomes. The "ground truth" is defined by the measurable parameters and limits set in the ISO standards.

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

Not applicable. Adjudication methods like 2+1 or 3+1 typically refer to expert review processes in clinical studies or image interpretation, which are not detailed here. The conformance to standards is based on physical and chemical testing.

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. The document explicitly states: "No clinical data was collected or provided to support substantial equivalence between the subject and predicate devices." Therefore, no MRMC study, AI assistance, or human reader improvement data is present.

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

Not applicable. This device is a root canal filling resin, a physical material, not an algorithm or AI software. Therefore, the concept of "standalone algorithm performance" does not apply.

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

The ground truth used for proving the device's performance is conformance to established international standards for dental materials, specifically ISO 6876:2012 for root canal sealing materials, and the ISO 10993 series for biological evaluation of medical devices (biocompatibility). The success of the device is measured against the physical, chemical, and biological requirements outlined in these standards.

8. The sample size for the training set

Not applicable. This is a physical medical device (a resin), not an AI algorithm or model that requires a training set.

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

Not applicable, as there is no training set for this type of device.

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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

September 26, 2019

Diadent Group International Myung Sub Kim Quality Assurance Manager 16. Osongsaengmyeong 4-ro. Osong-eup, Heungdeok-gu Cheongji-si, 28161 KOREA

Re: K182009

Trade/Device Name: DIA-PROSEAL Regulation Number: 21 CFR 872.3820 Regulation Name: Root Canal Filling Resin Regulatory Class: Class II Product Code: KIF Dated: August 30, 2019 Received: August 30, 2019

Dear Myung Sub Kim:

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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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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 Nandkumar, PhD Acting 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K182009

Device Name

DIA-PROSEAL

Indications for Use (Describe)

DIA-PROSEAL is used for permanent sealing of root canals in secondary dentition with gutta percha points.

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) 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."

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

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510(k) Summary

5.0 Application Information

Date Prepared:	26th Sep, 2019
Company Name andAddress:	DiaDent Group International16, Osongsaengmyeong 4-ro, Osong-eup, Heundeok-gu, Cheongju-si, Chungcheongbuk-do, 28161, Republic of Korea
Contact Person:	Myung Sub KimQuality Assurance ManagerPhone: +82-43-266-2315FAX: +82-43-235-2315Email: diadent32@diadent.co.kr

5.1 Device Information

Device Type:	Root Canal Filling Resin
Regulation Description:	Root Canal Filling Resin
Review Panel:	Dental
Regulation Number:	21 CFR 872.3820
Product Code:	KIF
Device Class:	II
Device Name:	DIA-PROSEAL

5.2 Predicate Devices

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

510(k) Number:	K960548
Applicant:	Dentsply International
Device Name:	AH Plus Root Canal Sealer
Regulation Number:	21 CFR 872.3820
Product Code:	KIF
Device Class:	II

5.3 Device Description

DIA-PROSEAL Root Canal Sealer is two-component systems that react via an epoxide/amine chemical reaction to case setting.

5.4 Intended Use/Indications for Use

DIA-PROSEAL is used for permanent sealing of root canals in secondary dentition with gutta percha points.

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5.5 Technological Characteristics

This device compares to the legally marketed devices as follows:

	Subject Device	Primary Predicate Device	Discuss
Product name	Dia-ProSeal	AH Plus
Manufacturer	DiaDent Group International	Dentsply
510K Number	K182009	K960548
Product Code	KIF	KIF
Intended use	DIA-PROSEAL is used for permanentsealing of root canals in secondarydentition with gutta percha points.	AH Plus Root Canal Sealer is used forpermanent sealing of root canalsfollowing established endodonticprocedures.	Equivalent
Image	Image: Dia-Proseal product packaging	Image: AH Plus product packaging
Mainingredient	BaseBisphenol A epoxy resinBisphenol F epoxy resinZirconium dioxideIron oxidesilicaCalcium tungstateCatalystamine-containing paste	Paste ABisphenol A epoxy resinBisphenol F epoxy resinzirconium oxideIron oxide PigmentssilicaCalcium tungstatePaste Bamine-containing paste	The mainingredientsof AH Plusand of Dia-Prosealare similar.They areboth two-componentsystemthat useepoxide/aminereaction tocausesetting.
Resin SealerType	Epoxy resin based sealers	Epoxy resin based sealers	equivalent
Devicedescription	DiaProSeal Root Canal Sealer consistsof two components, the epoxy resinpaste(Base) and the amine-containingpaste(Catalyst) portions which aremixed prior to insertion into the rootcanal.DiaProSeal Root Canal Sealer is two-component systems that react via anepoxide/amine chemical reaction tocause setting.	AH Plus Root Canal sealer is a two-component paste: paste root canalsealer based on epoxy-amine reinchemistry. This is easy-to-mix sealeradapts closely to the walls of theprepared root canal and providesoutstanding long-term dimensionalstability with minimal shrinkage uponsetting.The final product consists of twocomponents, the epoxy resinpaste(PasteA) and the amine-containing paste(PasteB) portionswhich are mixed prior to insertion intothe root canal	equivalent
Directionfor	Application Method	Preparation	equivalent

Use	1. Isolate the site with rubber dam.Prepare and shape the root canal.	1. Prior to the application of the
	2. Remove any debris inside the rootcanal. Disinfect and clean the root canalthoroughly with Sodium Hypochlorite orEDTA solution and dry it completely.	material prepare, clean, and dry theroot canals to be filled using state-of-the-art endodontic techniques.
	3) Open the safety cap of DIAPROSEALand squeeze out the vase material(yellow) and the catalyst material(white)in 1:1 ratio from the dual syringe onto amixing pad. (Due to the differentviscosity of the vase material and thecatalyst material, they may be dispensedat a different speed).	Dosage and mixing
	4. Using a mixing stick or metal spatula,mix the base material (yellow) and thecatalyst material(white) for 10-20seconds until they are completely mixedtogether and have turned into an ivorycolor.	1. Using a metal spatula 2, mix equalvolume units (1:1) of paste A (ambercolor) and paste B (white color) of AHPlus® root canal sealer on a glass slabor the mixing pad supplied with thepackage. Mix to a homogeneousconsistency.
	5. Measure the length of the root canalby using an electronic apex locator or afile. Select a gutta percha pointaccordingly. Apply and coat a smallamount of the mixture to the guttapercha point and insert the point towardsthe apex slowly. alternatively, dentistsmay choose to apply the mixture with apaper point, a reamer, or Dia-Spiral Filler(Lentulo spiral). In order to Prevent theformation and entrapment of air bubblesand overfilling the canal, the mixture-coated points must be inserted veryslowly in a clockwise direction duringobturation and withdrawn in a counterclock wise direction. If Lentulo spiral isused, advance and withdraw the Lentulospiral slowly to the apex at very lowspeed.	2. Tightly close tubes after use.3. Do not exchange caps of tubes. Thewhite cap belongs to paste A; the greyсарbelongs to paste B.Master-Point-Technique1. Select a gutta-percha point (oralternatively a paper point or a reamer)of the size of the last instrument usedduring apical preparation.2. Wet the canal walls with the materialthrough a pumping or simultaneouslyrotating movement in a counter-clockwise direction of thepoint/reamer. Alternatively, apply thematerial onto the tip of a Lentulo spiral.3. Advance the Lentulo spiral slowly tothe apex running at very low speed.Avoid theformation of air bubbles in the materialand overfilling of the canal.4. Withdraw Lentulo very slowly stillrunning at low speed.5. Dip disinfected and dry master pointinto the material and insert it into thecanal witha slow pumping motion.
	6. Once the procedure is done, take anX-Ray to check the seal.

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Chemicalreactionmechanism			equivalent
PerformanceStandardConformance	ISO6876	ISO6876	equivalent
Physical andMechanicalProperties	-. setting time-. Film thickness-. radiopacity-. solubility-. Flow	-. Working time-. film thickness-. radiopacity-. Solubility	equivalent
Biocompatibility	Yes	Yes	equivalent
Use	Prescription/Hospital	Prescription/Hospital	equivalent
Delivery forms(Design)	Manual mixing of Base and Catalyst	Manual mixing of paste A and Paste B	equivalent

As demonstrated in the above comparison table, the subject and predicate devices have similar indication for uses, main ingredients, contents, biocompatibility, and conformance with standards. Also, the subject and predicate devices are using the same chemical reaction and classified as the same resin type (Epoxy resin based sealers) as a two part mixture design.

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5.6 Non-Clinical Performance Data

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

Standards	Contents	Relevant Tests(Performed)
ISO 7405:2008	Dentistry—Evaluation of biocompatibility ofmedical devices used in dentistry	-
ISO 10993-1:2009	Biological evaluation of medical devices - Part1: Evaluation and testing within a riskmanagement process	-
ISO 10993-3:2014	Biological evaluation of medical devices - Part3: Tests for genotoxicity, carcinogenicity andreproductive toxicity	•Bacterial Reversemutation
ISO 10993-5:2009	Biological evaluation of medical devices - Part5: Tests for in vitro cytotoxicity	•Cytotoxicity
ISO 10993-10:2010	Biological evaluation of medical devices - Part10: Tests for irritation and skin sensitization	•Sensitization•Irritation/Intracutaneousreactivity
ISO 10993-11:2017	Biological evaluation of medical devices - Part11: Tests for systemic toxicity	•Acute systemic toxicity
ISO 6876:2012	Dentistry — Root canal sealing materials	•Setting time•Film Thickness•Radio-opacity•Solubility•Flow

5.7 Clinical Performance Data

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

5.8 Conclusions

Based on conclusions drawn from the testing results, the substantially equivalent to our legally marketed 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.