Diapaste

K190091 · DiaDent Group International · KIF · Mar 27, 2020 · Dental

Device Facts

• Record ID: K190091
• Device Name: Diapaste
• Applicant: DiaDent Group International
• Product Code: KIF · Dental
• Decision Date: Mar 27, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3820
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

Aqueous ointment material that temporarily fills the root canal for the following indications: - Apexification - Temporary root filling - Root canal filling for primary teeth - Vital pulpotomy - Temporary pulp capping

Device Story

Diapaste is a calcium hydroxide-based aqueous ointment used as a temporary root canal filling material. It is supplied in a syringe with disposable tips for direct application by dental professionals. The device functions as a temporary dressing for endodontic procedures, including apexification, pulpotomy, and pulp capping. It provides radiopacity for clinical visualization during treatment. The paste is intended for temporary use (29 days or less) and is removed during subsequent permanent root canal obturation. By maintaining a high pH environment, it aids in disinfection and healing within the root canal system, benefiting patients by facilitating successful endodontic therapy.

Clinical Evidence

Bench testing only. No clinical data provided. Performance testing demonstrated compliance with ISO 6876 for flowability (21mm), film thickness (45µm), and radiopacity (5.3mm Al). Biocompatibility was verified per ISO 10993-1, -3, -5, -10, -11, and ISO 7405, confirming the material is non-cytotoxic, non-sensitizing, and non-genotoxic.

Technological Characteristics

Calcium hydroxide-based aqueous ointment. Composition: calcium hydroxide, calcium carbonate, zinc oxide, barium sulfate, water, polyethylene glycol 400, polysorbate (Tween80). Form factor: syringe with disposable tips. Standards: ISO 6876 (root canal sealing), ISO 10993 series (biocompatibility), ISO 7405 (dental biocompatibility). Non-electronic, non-powered device.

Indications for Use

Indicated for apexification, temporary root filling, root canal filling for primary teeth, vital pulpotomy, and temporary pulp capping in patients requiring temporary root canal 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

• Metapaste (K032605)
• ApexCal (K060365)

Submission Summary (Full Text)

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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.

March 27, 2020

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

Re: K190091

Trade/Device Name: Diapaste Regulation Number: 21 CFR 872.3820 Regulation Name: Root Canal Filling Resin Regulatory Class: Class II Product Code: KIF Dated: February 19, 2020 Received: February 20, 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 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 ([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 Food and Drug Administration

## Indications for Use

510(k) Number (if known) K190091

Device Name DIAPASTE

Indications for Use (Describe)

Aqueous ointment material that temporarily fills the root canal for the following indications:

- Apexification

- Temporary root filling
- Root canal filling for primary teeth

- Vital pulpotomy

- Temporary pulp capping

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)

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## K190091 Diadent Group International

# 510(k) Summary

### 1 Application Information

| Date Prepared: | March 26, 2020 |
|------------------------------|------------------------------------------------------------------------------------------------------------------|
| Company Name and<br>Address: | DiaDent Group International |
| | 16, Osongsaengmyeong 4-ro, Osong-eup, Heungdeok-gu, Cheongju-<br>si, Chungcheongbuk-do, 28161, Republic of Korea |
| Contact Person: | Kab Sun, Lee |
| | Quality Assurance Manager |
| | Phone: [phone] |
| | FAX: [phone] |
| | Email: [e-mail] |

### 2 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: | DIAPASTE |

### 3 Predicate Devices

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

| | Primary Predicate Device | Reference Predicate Device |
|--------------------|--------------------------|----------------------------|
| 510(k) Number: | K032605 | K060365 |
| Applicant: | Meta Biomed Co., Ltd. | Ivoclar Vivadent |
| Device Name: | Metapaste | ApexCal |
| Regulation Number: | 21 CFR 872.3820 | 21 CFR 872.3250 |
| Product Code: | KIF | EJK |
| Device Class: | II | II |

## 4 Device Configuration

Each model configurations of subject device are described as following:

| Model Name | Contents |
|---------------------|---------------------------------------------------|
| DiaPaste Type A | 1 syringe(2g), 20 disposable tips, 1 silicone cap |
| DiaPaste Type B | 1 syringe(2g), 10 disposable tips, 1 silicone cap |
| DiaPaste Type C | 1 syringe(2g), 4 disposable tips, 1 silicone cap |
| DiaPaste Refill Kit | 1 syringe(2g) |
| DiaPaste Intro Kit | 1 syringe(0.5g), 4 disposable tips 1 silicone cap |

## 5 Device Description

Diapaste is a calcium hydroxide paste with barium sulfate, used as a temporary root canal filling material.

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## K190091

## Diadent Group International

### 6 Intended Use/Indications for Use

Aqueous ointment material that temporarily fills the root canal for the following indications:

- · Apexification
- · Temporary root filling
- · Root canal filling for primary teeth
- · Vital pulpotomy
- · Temporary pulp capping

## 7 Comparison Table and Discussion

#### This device compares to the legally marketed devices as follows:

| | Subject Device | Primary Predicate<br>Device | Reference Predicate<br>Device | |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| | DiaPaste | Metapaste | ApexCal | Discussion |
| Regulation<br>Number: | 21 CFR 872.3820 | 21 CFR 872.3820 | 21 CFR 872.3250 | |
| 510(k)<br>Number | K190091 | K032605 | K060365 | - |
| Indication<br>for Use | Aqueous ointment<br>material that<br>temporarily fills the<br>root canal for the<br>following<br>indications:<br>- Apexification<br>- Temporary root filling<br>- Root canal filling for<br>primary teeth<br>- Vital pulpotomy<br>- Temporary pulp<br>capping | Metapaste is a<br>biocompatible root canal<br>sealer used for the<br>temporary filling of root<br>canals after endodontic<br>surgery. Metapaste can be<br>used on its own and for<br>vital pulpectomies in<br>decidious teeth.<br>Metapaste is intended for<br>use by qualified healthcare<br>personnel trained in its<br>use. | ApexCAL is a Calcium<br>Hydroxide paste that has a<br>creamy consistency and is<br>suitable for several<br>indications including:<br>* Temporary disinfectant<br>dressings in the obturation<br>of root canals;<br>* Indirect pulp capping or<br>management of deep<br>caries lesions; or<br>* Direct pulp capping. | |
| Composition | - Calcium hydroxide<br>- Calcium carbonate<br>- Zinc oxide<br>- Barium sulfate<br>- Water<br>- Polyethylene glycol<br>400<br>- Polysorbate<br>(Tween80) | Calcium Hydroxide<br>Barium Sulfate<br>Poly propylene glycol | - Calcium hydroxide<br>- Bismuth carbonate<br>- Zinc oxide<br>- Polyethylene glycol<br>- glycerin<br>- Water | |
| Period of<br>Use | Temporary<br>(remains in the body for<br>29 days or less) | Temporary | Temporary | equivalent |
| Physical<br>properties | Conformed to ISO 6876<br>- Flowability<br>- Film Thickness<br>- Radio-opacity | Conformed to ISO 6876 | | equivalent |
| Biocompa<br>tibility | Biocompatible<br>- Cytotoxicity<br>- Sensitization<br>- Acute Systemic toxicity<br>- Oral Mucosa irritation<br>- Genetoxicity-<br>Bacterial Reverse<br>Mutation<br>- Genetoxicity-<br>Micronucleus<br>test | Biocompatible<br>Freedom from toxicity per<br>ISO/TR 7405 Agar<br>diffusion test | Biocompatible | equivalent |
| Package<br>Contents | • Syringe<br>• Disposable Tip<br>• Silicone Cap | • 2.2g paste in a syringe<br>• Disposable tips<br>• One ring rotator for the<br>direction control of the tip | • 2 syringes 2.5g each<br>• 15 application tips | - |

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## K190091

## Diadent Group International

## Differences

## - Indication For Use

| DiaPaste<br>(K190091) | Primary Predicate Device<br>(Metapaste, K032605) | Discussion |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Aqueous ointment material<br>that temporarily fills the root<br>canal for the following<br>indications:<br>· Apexification<br>· Temporary root filling<br>· Root canal filling for<br>primary teeth<br>· Vital pulpotomy<br>· Temporary pulp capping | Metapaste is a<br>biocompatible root canal<br>sealer used for the<br>temporary filling of root<br>canals after endodontic<br>surgery.<br>Metapaste can be used on<br>its own and for vital<br>pulpectomies in decidious<br>teeth.<br>Metapaste is intended for<br>use by qualified healthcare<br>personnel trained in its use. | Diapaste and Primary predicate device<br>(Metapaste) can be used for apexification &<br>pulpectomy technique for root canal<br>treatment as temporary root canal filling<br>materials. The Indication for Use of Subject<br>and predicate devices has same contents.<br>In the DiaPaste's Indication for Use, there are<br>contents of Pulpotomy and Temporary pulp<br>capping that is not found in Indication of use<br>of Metapaste. It is a technique commonly<br>used of temporary root canal fillings and as<br>such does not affect the equivalence of<br>Indication of subject and predicate devices. |

## -Composition

| Subject Device | Primary Predicate Device<br>(K032605) | Reference Predicate<br>Device(K060365) | Discussion |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| - Calcium hydroxide<br>- Calcium carbonate<br>- Zinc oxide<br>- Barium sulfate<br>(Radiopaque)<br>- Water<br>- Polyethylene glycol 400<br>- Polysorbate (Tween80) | Calcium Hydroxide<br>Barium Sulfate<br>(Radiopaque)<br>Poly propylene glycol | - Calcium hydroxide<br>- Bismuth carbonate<br>- Zinc oxide<br>- Polyethylene glycol<br>- glycerin<br>- Water | The main ingredient of<br>subject and predicate<br>devices is Calcium<br>Hydroxide. and the<br>functions of other<br>additives are similar<br>(base, Radiopaque,<br>pH controller,<br>Stabilizer).<br>Also, the<br>biocompatibility of<br>subject device was<br>confirmed by<br>biological safety study. |

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#### Diadent Group International

#### 8. 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 | Root Canal Sealing materials |
|---------------|----------------------------------------------------------------------------------------------------------------------|
| -ISO 7405 | Dentistry - Evaluation Of Biocompatibility Of Medical Devices Used In Dentistry [Including: Amendment 1 (2013)] |
| -ISO 10993-1 | Biological evaluation of medical devices - Part 1:Evaluation and testing within a risk management process |
| -ISO 10993-3 | Biological Evaluation of Medical Devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity |
| -ISO 10993-5 | Biological evaluation of medical devices - Part 5. Tests for in vitro Cytotoxicity |
| -ISO 10993-10 | Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization |
| -ISO 10993-11 | -ISO 10993-11 - Biological Evaluation of Medical Devices - Part 11: Tests for Systemic Toxicity |

The following Performance tests were conducted.

- -Flowability
- -Film thickness
- -Radiopacity
- -Biocompatibility test

#### Performance test (Physical properties):

| Test | Requirement | Result | Pass/Fail |
|----------------|-------------------------------------------------------|--------------------------------------------------|-----------|
| Flowability | Each disc to have a diameter of not<br>less than 17mm | 21mm (mean value) | Pass |
| Film thickness | No more than 50µm | 45µm (mean value) | Pass |
| Radiopacity | Equivalent to not less than 3mm of<br>Aluminum | Not less than 3mm of<br>Aluminum (approx. 5.3mm) | Pass |

## 9. Conclusion

Based on the above information and all data provided in this submission, including comparison of intended uses, technological characteristics discussion of differences of subject and predicate devices, show that the subject device and the predicate device have similar technical characteristic and chemical composition.

It is demonstrated that the subject device and the legally marketed devices identified in this submission are substantially equivalent.