DiaPaste

K210333 · DiaDent Group International · KIF · Mar 25, 2021 · Dental

Device Facts

• Record ID: K210333
• Device Name: DiaPaste
• Applicant: DiaDent Group International
• Product Code: KIF · Dental
• Decision Date: Mar 25, 2021
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.3820
• Device Class: Class 2
• Attributes: Therapeutic

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 and a silicone cap. The device is applied by a dental professional during endodontic procedures to fill the root canal space temporarily (up to 29 days). It functions as a physical barrier and therapeutic agent for apexification, pulpotomy, and pulp capping. The paste contains barium sulfate for radiopacity, allowing clinicians to verify placement via X-ray. The device is intended for clinical use by dentists.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing, including physical property evaluation (flowability, film thickness, radiopacity per ISO 6876) and biocompatibility testing (cytotoxicity, sensitization, irritation, genotoxicity, systemic toxicity, and implantation per ISO 10993 series).

Technological Characteristics

Calcium hydroxide-based aqueous ointment. Ingredients: Calcium hydroxide, titanium dioxide, zinc oxide, barium sulfate, water, polyether polyol, polysorbate (Tween80). Form factor: Syringe with disposable tips. Standards: ISO 6876 (root canal sealing), ISO 7405 (dentistry biocompatibility), ISO 10993-1/3/5/10/11 (biological evaluation).

Indications for Use

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

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

• DiaPaste (K190091)

Submission Summary (Full Text)

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March 25, 2021

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

Re: K210333

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 25, 2021 Received: February 26, 2021

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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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 (OS) 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,

Michael E. Adjodha, M.ChE. Assistant 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) K210333

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) |
|-------------------------------------------------|
|-------------------------------------------------|

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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K210333

### Diadent Group International

# Special 510(k) Summary

### 1 Application Information

| Date Prepared: | 01 Feb, 2021 |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| Company Name and Address: | DiaDent Group International<br>16, Osongsaengmyeong 4-ro, Osong-eup, Heungdeok-gu, Cheongju-<br>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

| 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 |
|--------------------|-----------------------------|
| 510(k) Number: | K190091 |
| Applicant: | DiaDent Group International |
| Device Name: | DiaPaste |
| Regulation Number: | 21 CFR 872.3820 |
| Product Code: | KIF |
| Device Class: | 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, 1silicone cap |
| DiaPaste Type B | 1 syringe(2g), 10 disposable tips, 1silicone cap |
| DiaPaste Type C | 1 syringe(2g), 4 disposable tips, 1silicone 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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### K210333

### 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:

| | Reference Predicate Device | Subject Device | |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| | DiaPaste | DiaPaste(Special 510k) | Discussion |
| Regulation<br>Number: | 21 CFR 872.3820 | 21 CFR 872.3820 | - |
| 510(k)<br>Number | K190091 | K210333 | - |
| Indication<br>for Use | Aqueous ointment material that<br>temporarily fills the root canal for the<br>following indications:<br>• Apexification<br>• Temporary root filling<br>• Root canal filling for primary<br>teeth<br>• Vital pulpotomy<br>• Temporary pulp capping | Aqueous ointment material that<br>temporarily fills the root canal for the<br>following indications:<br>• Apexification<br>• Temporary root filling<br>• Root canal filling for primary teeth<br>• Vital pulpotomy<br>• Temporary pulp capping | equivalent |
| Compositi<br>on | -. Polyoxymethylene sorbitan<br>monooleate<br>-. Polyethylene glycol<br>-. Distilled water<br>-. Barium sulfate<br>-. Zinc oxide<br>-. Calcium hydroxide<br>-. Calcium carbonate | -. Calcium hydroxide<br>-. Titanium dioxide<br>-. Zinc oxide<br>-. Barium sulfate<br>-. Water<br>-. Polyether Polyol<br>-. Polysorbate (Tween80) | - |
| Period of<br>Use | Temporary<br>(remains in the body for 29 days or<br>less) | Temporary<br>(remains in the body for 29 days or<br>less) | equivalent |
| Physical<br>properties | Conformed to ISO 6876<br>- Flowability<br>- Film Thickness<br>- Radio-opacity | Conformed to ISO 6876<br>- Flowability<br>- Film Thickness<br>- Radio-opacity | equivalent |
| Biocompa<br>tibility | Biocompatible<br>- Cytotoxicity<br>- Sensitization<br>- Acute Systemic toxicity<br>- Oral Mucosa irritation<br>- Genetoxicity-Bacterial Reverse<br>Mutation<br>- Genetoxicity- Micronucleus test | Biocompatible<br>- Cytotoxicity<br>- Sensitization<br>- Irritation Test<br>- Genotoxicity Test<br>- Acute Systemic Toxicity Test<br>- Sub chronic Toxicity test<br>- Implantation Test | equivalent |
| Package<br>Contents | •Syringe<br>•Disposable Tip<br>•Silicone Cap | •Syringe<br>•Disposable Tip<br>•Silicone Cap | - |

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### Differences

### -Composition

| Composition | | |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Reference Predicate Device | Subject Device | Discussion |
| • Polyoxymethylene sorbitan<br>monooleate<br>• Polyethylene glycol<br>• Distilled water<br>• Barium sulfate<br>• Zinc oxide<br>• Calcium hydroxide<br>• Calcium carbonate | • Calcium hydroxide<br>• Titanium dioxide<br>• Zinc oxide<br>• Barium sulfate<br>• Water<br>• Polyether Polyol<br>• Polysorbate (Tween80) | Raw materials except Titanium dioxide is the same as<br>the before medical device. The reason for this change<br>is product improvement due to consumer request.<br>and the biocompatibility of subject device was<br>confirmed by biological safety study. |

### 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<br>[Including: Amendment 1 (2013)] |
| -ISO 10993-1 | Biological evaluation of medical devices - Part 1:Evaluation and testing within a<br>risk management process |
| -ISO 10993-3 | Biological Evaluation of Medical Devices - Part 3: Tests for genotoxicity,<br>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<br>Sensitization |
| -ISO 10993-11 | 10993-11 - Biological Evaluation of Medical Devices - Part 11: Tests for<br>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 | 18mm (mean value) | Pass |
| Film thickness | No more than 50µm | 23µm (mean value) | Pass |
| Radiopacity | Equivalent to not less than 3mm of<br>Aluminum | Not less than 3mm of<br>Aluminum (approx. 4.1mm) | Pass |

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### 9. Conclusion

"Root Canal Filling Materials (model name: DiaPaste)" was compared to "Root Canal Filling Materials (model name: Diapaste) which has similar purpose of use, principle of action, method of use and test specifications. The purpose of use, principle of action, test standard, and method of use were the same as the comparison product, but there were differences in performance, and the raw materials were similar except for some components. In addition, there were no cases of biological side effects reported so far for the licensed product, and the biological safety test results for the applied product were judged as "suitable" for all items. DiaPaste is determined to have a level of biological safety that satisfies risk-benefit analysis based on the clinical use history of similar market products when used according to the intended use and methods of use.