DIA-ROOT BIO Sealer

K200175 · DiaDent Group International · KIF · Jun 25, 2020 · Dental

Device Facts

• Record ID: K200175
• Device Name: DIA-ROOT BIO Sealer
• Applicant: DiaDent Group International
• Product Code: KIF · Dental
• Decision Date: Jun 25, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3820
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

DIA-ROOT BIO Sealer is a premixed, hydraulic MTA-based root canal sealer supplied in a water-blocked syringe. It requires no mixing; it hardens upon reaction with moisture present in the oral cavity/dentin tubules. Used by dentists in clinical settings to provide permanent root canal sealing. The device is applied via disposable tips. It functions as an insoluble, radiopaque filling material. Benefits include simplified application and permanent sealing of the root canal system.

Clinical Evidence

No clinical data was collected or provided. Substantial equivalence is supported by bench testing and biocompatibility evaluation per ISO 6876:2012, ISO 7405:2018, and various ISO 10993 standards.

Technological Characteristics

Premixed hydraulic MTA-based cement. Materials: Calcium Silicate, Calcium Aluminate, Ytterbium Trifluoride, Zirconium Oxide, Silanamine, Hydroxypropyl Methylcellulose, Polyethylene glycol, Sorbitan, White Mineral Oil. Form factor: Syringe with disposable tips. Conforms to ISO 6876:2012 (flow, film thickness, solubility, radio-opacity). Non-sterile, 2-year shelf life.

Indications for Use

Indicated for permanent sealing of root canals in patients requiring root canal therapy. Can be used with or without obturation materials.

Regulatory Classification

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.

Predicate Devices

• Well-Root ST (K170950)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

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.

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 International<br>16, Osongsaengmyeong 4-ro, Osong-eup, Heungdeok-gu,<br>Cheongju-si, Chungcheongbuk-do, 28161, Republic of Korea |
| Contact Person | Kab Sun Lee<br>Quality Assurance Manager<br>Phone: [phone]<br>FAX: [phone]<br>Email: [e-mail] |

## 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

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 сар.

| 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

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.

#### 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 Group<br>International | Vericom Co., Ltd. | - |
|------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | DIA-ROOT BIO Sealer | Well-Root ST | - |
| Indications for<br>Use | DIA-ROOT BIO Sealer is<br>a MTA (mineral trioxide<br>aggregate) based root<br>canal sealer that provides<br>complete and permanent<br>sealing of root canals. It<br>can be used with or<br>without root canal<br>obturation materials. | Permanent sealing of root<br>canal | Equivalent |
| Description | DIA-ROOT BIO Sealer is<br>a hydraulic material, and a<br>premixed form that does<br>not require mixing. It<br>blocks the root canal by<br>hardening by reacting with<br>water in the oral cavity. It<br>is contained in a water-<br>blocked syringe and<br>corresponds to ISO<br>6876:2012, Dentistry-Root<br>canal sealing materials. | Well-Root ST is a<br>convenient premixed<br>ready-to use composition<br>which requires the<br>presence of water to set<br>and harden. The device is<br>contained in a plastic<br>syringe and the system<br>includes a plunger,<br>disposable tips, and a<br>holder. | Equivalent |
| Package Contents | -Syringe<br>-Disposable tip<br>-Silicone Cap | -Syringe<br>-Disposable tip<br>-Holder | Equivalent |
| Raw Materials | - Calcium Silicate<br>- Calcium Aluminate<br>- Ytterbium Trifluoride<br>- Zirconium Oxide<br>- Silanamine, 1,1,1-<br>trimethyl-N-<br>(trimethylsilyl)-,<br>hydrolysis products with<br>silica<br>- Hydroxypropyl<br>Methylcellulose<br>- Polyethylene glycol 400<br>- Polyethylene glycol 200<br>- Sorbitan<br>- White Mineral Oil- | -Calcium aluminosilicate<br>compound<br>- Calcium Sulfate<br>dihydrate<br>- Calcium sodium<br>phosphosilicate<br>- Zirconium Oxide<br>- Titanium Dioxide<br>- Polyethylene glycol<br>- Polypropylene glycol<br>- Propylene glycol | The main material,<br>calcium silicate of<br>the subject device<br>is similar to<br>calcium<br>aluminosilicate<br>compound of the<br>primary predicate<br>device. Also,<br>zirconium oxide<br>and polyethylene<br>glycol are<br>contained in both<br>subject device and<br>primary predicate<br>device. Through<br>the results of bench<br>and<br>biocompatibility<br>tests, this<br>difference does not<br>affect substantial<br>equivalence. |
| | | | |
| Principle of<br>operation | DIA-ROOT BIO Sealer is<br>a premixed form that does<br>not require mixing, and a<br>hydraulic material that<br>hardens by reacting water.<br>Also, it blocks the root<br>canal by hardening by<br>reacting with water in the<br>oral cavity. It is contained<br>in a water-blocked syringe<br>and is supplied with<br>disposable tips and<br>silicone caps. | Well-Root ST is a<br>convenient premixed<br>ready-to-use injectable<br>white hydraulic cement<br>paste developed for<br>permanent root canal<br>filling and sealing<br>applications. Well-Root<br>ST is an insoluble,<br>radiopaque material which<br>sets and hardens with<br>moisture providing from<br>dentin tubules during<br>hydration reaction. Well-<br>Root ST is packaged in a<br>pre-loaded syringe and is<br>supplied with disposable<br>tips. | Equivalent |
| Performance<br>Standard<br>Conformance | Conformed ISO 6876 | Conformed ISO 6876 | Equivalent |
| Physical and<br>Mechanical<br>properties | -Flow: Not less than 17<br>mm<br>-Film thickness: Not more<br>than 50 µm<br>-Solubility: Not more than<br>3 %<br>-Radio-opacity: Not less<br>than 3 mm | -Flow: Not less than 17<br>mm<br>-Film thickness: Not more<br>than 50 µm<br>-Solubility: Not more than<br>3 %<br>-Radio-opacity: Not less<br>than 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.