DIA-ROOT BIO MTA

K200174 · DiaDent Group International · KIF · Sep 18, 2020 · Dental

Device Facts

• Record ID: K200174
• Device Name: DIA-ROOT BIO MTA
• Applicant: DiaDent Group International
• Product Code: KIF · Dental
• Decision Date: Sep 18, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3820
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

DIA-ROOT BIO MTA is used for pulp capping (direct pulp capping or partial pulpotomy) and repair of root perforation. Other indications for use include: repair of root resorption, root end filling, apexification and pulpotomy.

Device Story

DIA-ROOT BIO MTA is a hydraulic dental cement used for endodontic procedures including pulp capping, pulpotomy, and root repair. The device is supplied as a powder to be mixed with distilled water by a clinician (dentist) using a provided spatula and mixing pad. Upon mixing, the material forms a colloidal gel that hardens to create a barrier. It is used in clinical/hospital settings. The hardened material provides a permanent seal for root canals and pulp protection. The device benefits patients by preserving pulp vitality and facilitating root development or repair. It is non-sterile and intended for permanent use.

Clinical Evidence

No clinical data was collected or provided. Substantial equivalence is supported by non-clinical bench testing and biocompatibility evaluation in accordance with ISO 6876:2012, ISO 7405:2018, and various ISO 10993 standards (cytotoxicity, genotoxicity, systemic toxicity, implantation effects).

Technological Characteristics

Hydraulic calcium silicate-based cement. Components: Calcium silicate, Zirconium dioxide, Citric acid, Silanamine hydrolysis products, Hydroxypropyl methylcellulose. Hardens via reaction with water. Physical properties: setting time, solubility, radiopacity. Supplied non-sterile with 3-year shelf life. Conforms to ISO 6876 and ISO 7405.

Indications for Use

Indicated for pulp capping, partial pulpotomy, repair of root perforation, repair of root resorption, root end filling, and apexification in patients requiring endodontic treatment.

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

• MTA ANGELUS (K112046)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and 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 18, 2020

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

Re: K200174

Trade/Device Name: Dia-root Bio Mta Regulation Number: 21 CFR 872.3820 Regulation Name: Root Canal Filling Resin Regulatory Class: Class II Product Code: KIF Dated: August 11, 2020 Received: August 19, 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

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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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| DEPARTMENT OF HEALTH AND HUMAN SERVICES<br>Food and Drug Administration | Form Approved: OMB No. 0910-0120<br>Expiration Date: 06/30/2020<br>See PRA Statement below. |
|-------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|
| Indications for Use | |

| 510(k) Number (if known) | K200174 |
|-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | DIA-ROOT BIO MTA |
| Indications for Use ( <i>Describe</i> ) | DIA-ROOT BIO MTA is used for pulp capping (direct pulp capping or partial pulpotomy) and repair of root perforation.<br>Other indications for use include: repair of root resorption, root end filling, apexification and pulpotomy. |
| Type of Use (Select one or both, as applicable) | <span> <label><input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> </span> <span> <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> </span> |

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# 5.0 510(k) Summary

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR 807.92.

# 5.1 Application Information

| Date Prepared: | Aug 11, 2020 |
|------------------|---------------------------------------------------------------|
| Company Name and | DiaDent Group International |
| Address: | 16, Osongsaengmyeong 4-ro, Osong-eup, Heungdeok-gu, Cheongju- |
| | si, Chungcheongbuk-do, 28161, Republic of Korea |
| Contact Person: | Kab Sun Lee |
| | Quality Assurance Manager |
| | Phone: [phone] |
| | FAX: [phone] |
| | Email: [e-mail] |

# 5.2 Device Information

| 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 MTA |

# 5.3 Predicate Devices

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

| 510(k) Number: | K112046 |
|--------------------|----------------------------------------------|
| Applicant: | ANGELUS INDUSTRIA DE PRODUCTOS ODONTOLOGICOS |
| Device Name: | MTA ANGELUS |
| Regulation Number: | 872.3820 |
| Product Code: | KIF |
| Device Class: | II |

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# 5.4 Device Description

| Package Composition | Composition |
|-----------------------|------------------------------------------------------------------------|
| DIA-ROOT BIO MTA 0.5g | 0.5g cap & body 1ea + Mixing pad 1ea (5 Sheet/Bundle) + Spatula<br>1ea |

The subject device is packaged with the following:

| No. | Component | Description |
|-----|------------|------------------------------------------------------------------|
| 1 | Cap & Body | It stores the contents. |
| 2 | Mixing pad | It is a pad used for mixing distilled water and the product. |
| 3 | Spatula | It is a spatula used for mixing distilled water and the product. |

# 5.5 Intended Use

DIA-ROOT BIO MTA is used for pulp capping (direct pulp capping or partial pulpotomy) and repair of root perforation. Other indications for use include: repair of root resorption, root end filling, apexification and pulpotomy.

#### 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 harmonized 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

Additional non-clinical bench testing demonstrates the safety and effectiveness of the subject device.

#### 5.7 Clinical Performance Data

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

#### 5.8 Technological characteristics

The subject device, DIA-ROOT BIO MTA has similar characteristics to the predicate device, MTA ANGELUS.

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First, the intend use of the subject device and predicate device is pulp capping and to repair of root perforation.

Second, both the subject device and predicate device are to react with water.

Third, both the subject device and predicate device confirm to ISO 6876 and have similar physical and mechanical properties; Setting time, Solubility, Radio-opacity. Also, they are biocompatible. Finally, they are supplied non-sterile state and have 3 years shelf-life.

The raw materials composition of the subject device is slightly different from the predicate device. However, the main material, Calcium silicate of the subject device is similar to Tricalcium silicate, Dicalcium silicate of the predicate device. Through the results of bench and biocompatibility tests, this difference does not raise any issue of safety and effectiveness.

| | Subject Device | Primary Predicate<br>Device | Discuss |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| 510(k) Number | - | K112046 | - |
| Product code | KIF | KIF | Equivalent |
| Device Class | II | II | Equivalent |
| Applicant | DiaDent Group<br>International | ANGELUS<br>INDUSTRIA DE<br>PRODUCTOS<br>ODONTOLOGICOS | - |
| Device Name | DIA-ROOT BIO MTA | MTA ANGELUS | - |
| Indications For<br>Use | DIA-ROOT BIO MTA<br>is used for pulp capping<br>(direct pulp capping or<br>partial pulpotomy) and<br>repair of root<br>perforation. Other<br>indications for use<br>include: repair of root<br>resorption, root end<br>filling, apexification<br>and pulpotomy. | - Treatment of<br>perforations of root<br>canal and furcation<br>caused iatrogenically or<br>by caries lesions<br>- Via canal treatment of<br>root perforation due to<br>internal resorption<br>- Surgical treatment of<br>root perforation due to<br>internal resorption<br>- Periapical surgery<br>with reverse filling<br>- Pulp capping<br>- Pulpotomy(removal of<br>affected coronal pulp to<br>preserve vitality of<br>remaining pulp tissue)<br>-<br>Apexogenesis(inductio<br>n of root development<br>in vital teeth with an<br>inflamed coronal pulp)<br>-<br>Apexification(induction<br>of formation of a<br>mineralized barrier at<br>the root tip of young | Equivalent |

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| Description | DIA-ROOT BIO MTA<br>is a hydraulic product<br>that hardens by reacting<br>with water. It is<br>designed for the<br>protection of pulp such<br>as direct pulp capping,<br>pulpotomy, and<br>perforation. | permanent teeth with<br>incomplete root<br>development and a<br>necrotic pulp)<br>MTA Angelus is a<br>mineral trioxide<br>aggregate cement used<br>for root repair during<br>endodontic treatment,<br>combining the powder<br>and liquid produces a<br>colloidal gel that<br>solidifies to form a<br>barrier. | Equivalent |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Package Contents | • Cap & Body<br>• Mixing pad<br>• Spatula | • Cap & Body<br>• Distilled Water<br>• Spoon | - |
| Composition | - Calcium silicate<br>- Zirconium dioxide<br>- Citric acid<br>- Silanamine, 1,1,1-<br>trimethyl-N-<br>(trimethylsilyl)-,hydrol<br>ysis products with silica<br>-Hydroxypropyl<br>methylcellulose | - Tricalcium silicate<br>- Dicalcium silicate<br>- Tricalcium aluminate<br>- Calcium oxide<br>- Bismuth oxide<br>- Distilled water | The main ingredients<br>are similar, with some<br>different ingredients.<br>However, the results of<br>biocompatibility and<br>performance tests<br>confirm that DIA-<br>ROOT BIO MTA<br>similar products are<br>equivalent. |
| Physical<br>properties | - Setting time<br>- Solubility<br>- Radiopacity | - Setting time<br>- Solubility<br>- Radiopacity | Equivalent |
| Use | Prescription / Hospital | Prescription / Hospital | Equivalent |
| Period of Use | Permanent | Permanent | Equivalent |
| Sterility | Non-sterile | Non-sterile | Equivalent |
| Shelf-life | 3 years | 3 years | Equivalent |
| Biocompatibility | Biocompatible | Biocompatible | Equivalent |
| Standards | ISO7405 | ISO7405 | - |

## 5.9 Conclusions

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.