CeraSeal

K190503 · Meta Biomed Co., Ltd. · KIF · Jun 7, 2019 · Dental

Device Facts

• Record ID: K190503
• Device Name: CeraSeal
• Applicant: Meta Biomed Co., Ltd.
• Product Code: KIF · Dental
• Decision Date: Jun 7, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3820
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Permanent obturation of the root canal following vital pulp-extirpation Permanent obturation of the root canal following removal of infected or necrotic pulp and placement of intracanal dressings CeraSeal is suitable for use in the single cone and lateral condensation technique.

Device Story

CeraSeal is a flowable, white, aesthetic paste used for permanent root canal filling. It consists of calcium silicate compounds, zirconium dioxide, and thickening agents. The device is applied directly into the root canal via a disposable tip. It functions as a hydraulic cement that cures slowly by absorbing ambient water within the root canal. Used by dentists in clinical settings, it provides a permanent seal for the root canal system. The device is supplied as a non-sterile, ready-to-use paste in a syringe, facilitating efficient delivery during endodontic procedures.

Clinical Evidence

Bench testing only. Biocompatibility testing performed per ISO 10993-1, -5, -10, and -11. Performance testing (visual, capacity, package, flow, setting time, film thickness, solubility, radio-opacity) conducted per ISO 6876:2012. Shelf life testing also performed per ISO 6876.

Technological Characteristics

Calcium silicate-based hydraulic cement paste. Ingredients: Zirconium dioxide, calcium silicates, 1,3-propanediol, thickening agent. Form factor: Flowable paste in pre-loaded syringe with disposable tips. Energy source: None (chemical curing via ambient water absorption). Standards: ISO 6876:2012 (performance), ISO 10993 series (biocompatibility). Sterility: Non-sterile.

Indications for Use

Indicated for permanent root canal obturation following vital pulp-extirpation or removal of infected/necrotic pulp with intracanal dressings. Suitable for single cone and lateral condensation techniques.

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

• iRoot SP (K080917)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

June 7, 2019

Meta Biomed Co., Ltd. % April Lee Consultant Withus Group Inc 106 Superior Irvine. California 92620

Re: K190503

Trade/Device Name: CeraSeal Regulation Number: 21 CFR 872.3820 Regulation Name: Root Canal Filling Resin Regulatory Class: Class II Product Code: KIF Dated: March 11, 2019 Received: March 19, 2019

Dear April 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.

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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 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.

Srinivas Nandkumar, Ph.D. Assistant Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known) K190503

Device Name CeraSeal

Indications for Use (Describe)

· Permanent obturation of the root canal following vital pulp-extirpation

· Permanent obturation of the root canal following removal of infected or necrotic pulp and placement of intracanal dressings

CeraSeal is suitable for use in the single cone and lateral condensation technique.

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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Image /page/3/Picture/0 description: The image shows the logo for Meta Biomed. The logo consists of a stylized tooth shape on the left, with the top half in dark blue and the bottom half in teal. To the right of the tooth shape are the words "META" in dark blue above the word "BIOMED" in teal. There is a registered trademark symbol next to the word META.

Address
270, Osongsaengmyeong 1-ro,
Osong-eup, Heungdeok-gu,
Cheongju-si, Chungcheongbuk-do,
Korea

Tel
[phone]

Fax
[phone]

META BIOMED CO.LTD.
E-mail

[e-mail]
http://www.meta-biomed.com

# 0(k) Summary

Submitter

META BIOMED CO., LTD. Suk Song Oh 270, Osongsaengmyeong 1-ro, Osong-eup, Heungdeok-gu, Cheongju-si, Chungcheongbuk-do, South Korea Email: [e-mail] Phone: [phone] Fax: [phone]

### Official Correspondent

K190503

Withus Group Inc April Lee 106 Superior, Irvine, CA 92620 USA Email: [e-mail] Phone: [phone] Fax: [phone]

### Device Information

- Trade Name: CeraSeal
- . Classification Name: resin, root canal filling
- Product Code: KIF
- Panel: Dental
- Regulation Number: 21 CFR 872.3820
- Device Class: Class II
- Date prepared: 02/20/2019

### Predicate Devices:

- K080917, iRoot SP manufactured by Innovative BioCeramix Inc.
### Device Description

CeraSeal is used for root canal filling after the removal of infected pulp tissue in the root canal. CeraSeal is in the form of a flowable paste and can be immediately applied inside the root canal using a disposable tip. material, and a thickening agent. This product characteristically cures slowly by absorbing the ambient water inside the root canal. It is white and aesthetic.

### Indication for Use

- Permanent obturation of the root canal following vital pulp-extirpation
- Permanent obturation of the root canal following removal of infected or necrotic pulp and placement of intracanal dressings

CeraSeal is suitable for use in the single cone and lateral condensation technique.

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Image /page/4/Picture/0 description: The image shows the logo for Meta Biomed. The logo consists of a stylized tooth shape on the left, with the top half in dark blue and the bottom half in teal. To the right of the tooth shape, the words "META" and "BIOMED" are stacked on top of each other, also in teal. The "META" has a registered trademark symbol next to it.

Address
270, Osongsaengmyeong 1-ro,
Osong-eup, Heungdeok-gu,
Cheongju-si, Chungcheongbuk-do,
Korea

Tel
[phone]

Fax
[phone]

## Non-clinical Testing

The following testing was conducted on our subject device:

- . Biocompatibility Tests according to ISO 10993-1:2009, ISO 10993-5:2009, ISO 10993-10:2010, ISO 10993-11:2006.
- Performance tests such as visual, capacity, package, flow, setting time, film thickness, solubility . and radio-opacity according to ISO 6876:2012.
- . Shelf Life test: ISO 6876 tests (extraneous matter, package, flow, setting time, film thickness and Solubility)

# Summary of Technological Characteristics:

The subject device and the predicate device have the same intended use and have the similar technological characteristics and are made of similar materials. They encompass the same range of physical and chemical properties. The subject device and predicate devices are packaged in similar material and use similar methods of application.

The subject device is different from the predicate devices in raw materials, however, the test results provided in this submission supports that it is substantially equivalent to the predicate device.

| | Subject Device | Predicate Device |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Meta Biomed Co., Ltd. | Innovative BioCeramix, Inc. |
| Device Name | CeraSeal | iRoot SP |
| 510(k) Number | NA | K080917 |
| Classification Name | resin, root canal filling | resin, root canal filling |
| Product Code | KIF | KIF |
| Regulation Number | 21 CFR 872.3820 | 21 CFR 872.3820 |
| Indications for use | ● Permanent obturation of the root canal following vital pulp-extirpation<br>● Permanent obturation of the root canal following removal of infected or necrotic pulp and placement of intracanal dressings<br>CeraSeal is suitable for use in the single cone and lateral condensation technique. | ● Permanent obturation of the root canal following vital pulp-extirpation<br>● Permanent obturation of the root canal following removal of infected or necrotic pulp and placement of intracanal dressings<br>iRoot SP is suitable for use in the single cone and lateral condensation technique. |

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Image /page/5/Picture/0 description: The image shows the logo for META BIOMED. The logo consists of a stylized tooth shape on the left, with the top half in dark blue and the bottom half in teal. To the right of the tooth shape is the text "META" in dark blue, with a registered trademark symbol above the A. Below "META" is the text "BIOMED" in teal.

Address 270, Osongsaengmyeong 1-ro, Osong-eup, Heungdeok-gu, Cheongju-si, Chungcheongbuk-do, Korea

[phone] Fax [phone]

Tel

[e-mail] http://www.meta-biomed.com

| | Insoluble, radiopaque material based on a<br>calcium silicate compound containing: | Insoluble, radiopaque material based on a<br>calcium silicate compound containing: |
|-------------------------------------|------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Thickening agent | Thickening agent |
| Raw Material | Zirconium dioxide<br>Calcium silicates<br>1, 3 Propanediol | Zirconium oxide filler<br>Calcium silicates<br>Calcium phosphate monobasic<br>Calcium hydroxide |
| Principle of Operation | identical | iRoot SP is a convenient premixed ready-<br>to-use injectable white hydraulic cement<br>paste developed for permanent root canal<br>filling and sealing applications. iRoot SP<br>is an insoluble, radiopaque material<br>which requires the presence of water to<br>set and harden. iRoot SP is packaged in a<br>pre-loaded syringe and is supplied with<br>disposable tips. |
| Performance Standard<br>Conformance | Conformed to ISO 6876 | Conformed to ISO 6876 |
| Biocompatibility | Yes | Yes |
| Use | Prescription / Hospital | Prescription / Hospital |
| Delivery Forms | Single Paste | Single Paste |
| Sterility | Non-sterile | Non-sterile |
| Shelf Life | 2 years | 2 years |

## Conclusion:

Based on documentation supplied with this submissions drawn from the testing results demonstrate that the subject device is substantially equivalent to our legally marketed predicate device.