DIA-ROOT BIO Sealer is a MTA (mineral trioxide aggregate) based root canal sealer that provides complete and permanent sealing of root canals. It can be used with or without root canal obturation materials.

Device Description

DIA-ROOT BIO Sealer is a hydraulic material, and a premixed form that does not require mixing. It blocks the root canal by hardening by reacting with water in the oral cavity. It is contained in a waterblocked syringe and corresponds to ISO 6876:2012, Dentistry-Root canal sealing materials. DIA-ROOT BIO Sealer has two models and they are packaged with components; Disposable tip, Silicone cap.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the DIA-ROOT BIO Sealer, structured according to your request:

Acceptance Criteria and Device Performance Study for DIA-ROOT BIO Sealer (K200175)

This document describes a 510(k) premarket notification for the DIA-ROOT BIO Sealer, a root canal filling resin. The submission aims to demonstrate substantial equivalence to a legally marketed predicate device (Well-Root ST). The performance assessment for this device is based on non-clinical performance data and biocompatibility tests, as no clinical data was submitted.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the DIA-ROOT BIO Sealer are derived from the international standard ISO 6876:2012, "Dentistry - Root canal sealing materials." The device's reported performance is compared to these criteria and also to the predicate device (Well-Root ST).

Performance Characteristic	Acceptance Criteria (ISO 6876:2012)	Reported Device Performance (DIA-ROOT BIO Sealer)	Predicate Device Performance (Well-Root ST)	Equivalence Assessment
Flow	Not less than 17 mm	Not less than 17 mm	Not less than 17 mm	Equivalent
Film Thickness	Not more than 50 µm	Not more than 50 µm	Not more than 50 µm	Equivalent
Solubility	Not more than 3 %	Not more than 3 %	Not more than 3 %	Equivalent
Radio-opacity	Not less than 3 mm	Not less than 3 mm	Not less than 3 mm	Equivalent
Biocompatibility	Conformance to ISO 7405, ISO 10993 series	Biocompatible	Biocompatible	Equivalent
Performance Standard	Conformed to ISO 6876	Conformed to ISO 6876	Conformed to ISO 6876	Equivalent

Note: The submission states, "The test results corresponded the requirements of standards. Therefore, the subject device is substantially equivalent to the primary predicate device."

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

Sample Size: The document does not explicitly state the specific number of units or samples used for each non-clinical test (Flow, Film Thickness, Solubility, Radio-opacity, Biocompatibility). It only refers to "tests conducted on the subject device."
Data Provenance: The tests are non-clinical in nature and were conducted to verify conformance to international standards. The country of origin of the data is not explicitly stated, but the applicant, DiaDent Group International, is based in the Republic of Korea. The data is retrospective (i.e., collected before the submission date for this premarket notification).

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

This section is not applicable as the provided documentation describes a non-clinical evaluation comparing a new device to a predicate device based on performance standards and biocompatibility, not on human interpretation of clinical data or images. Ground truth in this context would refer to the established values defined by the ISO standards, which are objective measurements, not expert consensus.

4. Adjudication Method for the Test Set

This section is not applicable as the evaluation involved objective physical and chemical testing against defined standard criteria, not subjective human assessment requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

An MRMC comparative effectiveness study was not done. The submission explicitly states: "No clinical data was collected or provided to support substantial equivalence between the subject and primary predicate device." The evaluation was based solely on non-clinical performance and biocompatibility.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This section is not applicable. The device is a physical medical device (root canal sealer), not an algorithm or AI-based software. Therefore, the concept of "standalone algorithm performance" does not apply.

7. Type of Ground Truth Used

The "ground truth" for the non-clinical tests was based on established objective criteria defined by international standards, specifically ISO 6876:2012 for physical and mechanical properties (Flow, Film Thickness, Solubility, Radio-opacity) and the ISO 10993 series for biocompatibility. This is a form of objective measurement/standard conformance rather than expert consensus, pathology, or outcomes data, as no clinical studies were performed.

8. Sample Size for the Training Set

This section is not applicable as the device is not an AI/ML algorithm requiring a training set.

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

This section is not applicable as the device is not an AI/ML algorithm requiring a training set.

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, 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.

June 25, 2020

Diadent Group International Kab Sun Lee Quality Assurance Manager 16, Osongsaengmyeong 4-ro, Osong-eup, Heungdeok-gu Cheongju-si, Chungcheongbuk-do, 28161 Republic of Korea

Re: K200175

Trade/Device Name: DIA-ROOT BIO Sealer Regulation Number: 21 CFR 872.3820 Regulation Name: Root Canal Filling Resin Regulatory Class: Class II Product Code: KIF Dated: March 25, 2020 Received: March 27, 2020

Dear Kab Sun 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

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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 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 medical devices and radiation-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) K200175

Device Name DIA-ROOT BIO Sealer

Indications for Use (Describe)

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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510(k) Summary (K200175)

This summary of 510(k) substantial equivalence information is submitted in accordance with the requirements of 21 CFR 807.92.

1. Application Information

Date Prepared	Jun 24, 2020
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	K200175
Device Type	Resin, Root Canal Filling
Regulation Description	Root canal filling resin.
Review Panel	Dental
Regulation Number	21 CFR 872.3820
Product Code	KIF
Device Class	II
Device Name	DIA-ROOT BIO Sealer

3. Primary Predicate Device

510(k) Number	K170950
Applicant	Vericom Co., Ltd.
Device Name	Well-Root ST
Regulation Number	21 CFR 872.3820
Product Code	KIF
Device Class	II

4. Device Description

Model Name	Composition
DIA-ROOT BIO Sealer 2.0g	2.0g syringe 1ea + Disposable tip 20ea + Silicone cap 1ea
DIA-ROOT BIO Sealer 0.5g	0.5g syringe 1ea + Disposable tip 4ea + Silicone cap 1ea

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5. Indications for Use

6. Clinical Performance Data

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

7. Non-Clinical Performance Data

The performance and biological tests were conducted on the subject device; DIA-ROOT BIO Sealer according to the following standards.

ISO 6876:2012, Dentistry - Root canal sealing materials ISO 7405:2018, Dentistry - Evaluation of biocompatibility of medical devices used in dentistry ISO 10993-1:2018, 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

The test results corresponded the requirements of standards. Therefore, the subject device is substantially equivalent to the primary predicate device.

8. Technological Characteristics

The subject device, DIA-ROOT BIO Sealer has similar characteristics to the primary predicate device, Well-Root ST.

First, the indications for use of the subject device and primary predicate device is to seal root canal permanently. Our indications for use is more detailed than the predicate device, but it does not contain new indications.

Second, both the subject device and primary predicate device are premixed hydraulic materials, and to seal the root canal by hardening with water in the oral cavity. Also, they are contained in a syringe and supplied with disposable tips.

Third, both the subject device and primary predicate device confirm to ISO 6876 and have similar physical and mechanical properties; Flow, Film thickness, Solubility, Radio-opacity. Also, they are biocompatible.

Finally, they are supplied non-sterile state and have 2 years shelf-life.

The raw materials composition of the subject device is slightly different from the primary predicate device. However, the main material, Calcium silicate of the subject device is similar to Calcium aluminosilicate compound of the primary predicate device. Also, Zirconium Oxide and Polyethylene glycol are contained in both subject device and primary predicate device. Through the results of bench and biocompatibility tests, this difference does not affect substantial equivalance.

[Comparison table]

	Subject Device	Primary Predicate Device	Discuss
510(k) Number	K200175	K170950	-
Product Code	KIF	KIF	Equivalent
Device Class	II	II	Equivalent

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DiaDent Group International Product Name: DIA-ROOT BIO Sealer

Manufacturer	DiaDent GroupInternational	Vericom Co., Ltd.	-
Device Name	DIA-ROOT BIO Sealer	Well-Root ST	-
Indications forUse	DIA-ROOT BIO Sealer isa MTA (mineral trioxideaggregate) based rootcanal sealer that providescomplete and permanentsealing of root canals. Itcan be used with orwithout root canalobturation materials.	Permanent sealing of rootcanal	Equivalent
Description	DIA-ROOT BIO Sealer isa hydraulic material, and apremixed form that doesnot require mixing. Itblocks the root canal byhardening by reacting withwater in the oral cavity. Itis contained in a water-blocked syringe andcorresponds to ISO6876:2012, Dentistry-Rootcanal sealing materials.	Well-Root ST is aconvenient premixedready-to use compositionwhich requires thepresence of water to setand harden. The device iscontained in a plasticsyringe and the systemincludes a plunger,disposable tips, and aholder.	Equivalent
Package Contents	-Syringe-Disposable tip-Silicone Cap	-Syringe-Disposable tip-Holder	Equivalent
Raw Materials	- Calcium Silicate- Calcium Aluminate- Ytterbium Trifluoride- Zirconium Oxide- Silanamine, 1,1,1-trimethyl-N-(trimethylsilyl)-,hydrolysis products withsilica- HydroxypropylMethylcellulose- Polyethylene glycol 400- Polyethylene glycol 200- Sorbitan- White Mineral Oil-	-Calcium aluminosilicatecompound- Calcium Sulfatedihydrate- Calcium sodiumphosphosilicate- Zirconium Oxide- Titanium Dioxide- Polyethylene glycol- Polypropylene glycol- Propylene glycol	The main material,calcium silicate ofthe subject deviceis similar tocalciumaluminosilicatecompound of theprimary predicatedevice. Also,zirconium oxideand polyethyleneglycol arecontained in bothsubject device andprimary predicatedevice. Throughthe results of benchandbiocompatibilitytests, thisdifference does notaffect substantialequivalence.

Principle ofoperation	DIA-ROOT BIO Sealer isa premixed form that doesnot require mixing, and ahydraulic material thathardens by reacting water.Also, it blocks the rootcanal by hardening byreacting with water in theoral cavity. It is containedin a water-blocked syringeand is supplied withdisposable tips andsilicone caps.	Well-Root ST is aconvenient premixedready-to-use injectablewhite hydraulic cementpaste developed forpermanent root canalfilling and sealingapplications. Well-RootST is an insoluble,radiopaque material whichsets and hardens withmoisture providing fromdentin tubules duringhydration reaction. Well-Root ST is packaged in apre-loaded syringe and issupplied with disposabletips.	Equivalent
PerformanceStandardConformance	Conformed ISO 6876	Conformed ISO 6876	Equivalent
Physical andMechanicalproperties	-Flow: Not less than 17mm-Film thickness: Not morethan 50 µm-Solubility: Not more than3 %-Radio-opacity: Not lessthan 3 mm	-Flow: Not less than 17mm-Film thickness: Not morethan 50 µm-Solubility: Not more than3 %-Radio-opacity: Not lessthan 3mm	Equivalent
Biocompatibility	Biocompatible	Biocompatible	Equivalent
Use	Prescription / Hospital	Prescription / Hospital	Equivalent
Period of use	Permanent	Permanent	Equivalent
Sterility	Non-sterile	Non-sterile	Equivalent
Shelf-life	2 years	2 years	Equivalent

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9. Conclusions

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

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.