White Endoseal MTA

K212229 · Maruchi · KIF · Aug 13, 2021 · Dental

Device Facts

• Record ID: K212229
• Device Name: White Endoseal MTA
• Applicant: Maruchi
• Product Code: KIF · Dental
• Decision Date: Aug 13, 2021
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.3820
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Permanent root canal obturation

Device Story

White ENDOSEAL MTA is a root canal sealer supplied in a pre-loaded syringe. It is used by dental professionals in a clinical setting for permanent root canal obturation. The material is applied either alone or in combination with gutta-percha cones, injected gutta-percha, or core-carriers. The sealer functions by absorbing moisture from the root canal environment to initiate setting. By providing a seal within the root canal system, it aids in the success of endodontic procedures and benefits the patient by preventing reinfection of the canal space.

Clinical Evidence

Bench testing only. Performance testing included ISO 6876 standards (capacity, pH, flow, setting time, film thickness, solubility, radiopacity) and ISO 10993 biocompatibility testing (cytotoxicity, skin sensitization, acute systemic toxicity, and genotoxicity). All test results met preset criteria.

Technological Characteristics

Root canal sealer; paste-type; pre-loaded syringe; non-sterile. Composition: Zirconium dioxide, Dimethyl sulfoxide, Tricalcium silicate, Water, Bentonite Clay, Polyvinyl alcohol, Polyvinyl pyrrolidone, Lithium Carbonate. Conforms to ISO 6876. Sets via moisture absorption from the root canal environment.

Indications for Use

Indicated for permanent root canal obturation 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

• White ENDOSEAL MTA (K202015)

Submission Summary (Full Text)

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August 13, 2021

Maruchi Jang Sung Wook CEO 2-208, Medical Industry Complex Bldg., 42-10, Taejanggongdan-gil Wonju-si, Gangwon-do 26311 South Korea

Re: K212229

Trade/Device Name: White Endoseal MTA Regulation Number: 21 CFR 872.3820 Regulation Name: Root Canal Filling Resin Regulatory Class: Class II Product Code: KIF Dated: July 7, 2021 Received: July 16, 2021

Dear Jang Sung Wook:

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 and ENT 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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#### 4. INDICATION FOR USE STATEMENT

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

#### Indications for Use

510(k) Number (if known)

K212229

Device Name White ENDOSEAL MTA

Indications for Use (Describe) Permanent root canal obturation

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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#### 5. 510(k) SUMMARY - K212229

#### 510(k) Summary

Date: July 07, 2021

### 1. SUBMITTER

MARUCHI

2-208, Medical Industry Complex Bldg., 42-10, Taejanggongdan-gil, Wonju-si, Gangwon-do, 26311, Republic of Korea TEL : [phone] FAX : [phone] Contact Name: Sung Wook, Jang Email: [e-mail]

#### 2. DEVICE

·Trade Name: White ENDOSEAL MTA ·Common Name: Root Filling Material · Classification Name: Resin, Root canal filling ·Regulation Number 872.3820 ·Class: 2 ·Classification Product Code: KIF

### 3. CLEARED DEVICE (PREDICATE DEVICE)

K202015, White ENDOSEAL MTA, MARUCHI

### 4. DEVICE DESCRIPTION

White ENDOSEAL MTA is a root canal sealer conforming to ISO 6876, in a pre-loaded syringe that does not require any pre-mixing and is set by absorbing moisture from the root canal environment.

The sealer can be used either alone or in combination with gutta-percha obturating cones, injected gutta-percha material or core-carriers, master cones.

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# 5. INDICATIONS FOR USE

Permanent root canal obturation

# 6. PERFORMANCE TESTING (NON-CLINICAL)

The following test articles were tested based on the referenced standard. All the test results met the preset test criteria.

- Testing institution's method Capacity, pH
- ISO 6876 Package, Extraneous matter, Flow, Setting time, Film Thickness, . Solubility, Radio-opacity
- ISO 10993-5 Cytotoxicity (MTT) .
- . ISO 10993-10 - Guinea Pig Maximization Test for Skin sensitization (GPMT)
- ISO 10993-11 Acute systemic toxicity .
- ISO 10993-3 Genotoxicity (Mammalian chromosome aberration test & • Bacterial Reverse Mutation)

| | Modified device | Cleared device (Predicate device) | Discuss/Justify the Differences |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------|
| 510(k) Number | New | K202015 | - |
| Trade Name | White ENDOSEAL MTA | White ENDOSEAL MTA | - |
| Manufacturer | MARUCHI | MARUCHI | - |
| Common Name | Root Filling Material | Root Filling Material | Equivalent |
| Classification Name | Resin, Root canal filling | Resin, Root canal filling | Equivalent |
| Device Class | 2 | 2 | Equivalent |
| Product Code | KIF | KIF | Equivalent |
| Device Description | White ENDOSEAL MTA is a root canal sealer conforming to ISO 6876, in a | This product is the root canal sealer conforming to ISO 6876. This is a pre- | Equivalent |
| | | | |
| | pre-loaded syringe that does not require any pre-mixing and is set by absorbing moisture from the root canal environment. The sealer can be used either alone or in combination with gutta-percha obturating cones, injected gutta-percha material or core-carriers, master cones. | loaded syringe type that does not require mixing and is set by absorbing the moisture around the root canal. | |
| Indications for Use | Permanent root canal obturation | Permanent root canal obturation | Equivalent |
| Intended user | Dental professional | Dental professional | Equivalent |
| Standards | ISO 6876 | ISO 6876 | Equivalent |
| Physical properties | Setting time: 2 hours 27 minutes<br>Flow: 26.31 mm<br>Radiopacity: 7.5 mm<br>Film thickness: 26 μm<br>Solubility: 0.11 % | Setting time: 29 min<br>Flow: 22 mm<br>Radiopacity: 7.7 mm<br>Film thickness: 14 μm<br>Solubility: 0.3 % | Differences |
| Chemical Composition | -Zirconium dioxide<br>-Dimethyl sulfoxide<br>-Calcium silicate (Tricalcium silicate)<br>-Water<br>-Bentonite Clay<br>-Polyvinyl alcohol<br>-Polyvinyl pyrrolidone<br>-Lithium Carbonate | -Zirconium dioxide<br>-Dimethyl sulfoxide<br>-Calcium silicate (Tricalcium silicate)<br>-Water<br>-Bentonite Clay<br>-Polyvinyl alcohol<br>-Polyvinyl pyrrolidone<br>-Lithium Carbonate | Equivalent |
| Liquid Formula | Paste type | Paste type | Equivalent |
| Packaging | Pre-loaded syringe | Pre-loaded syringe | Equivalent |
| Sterile | Non-sterile | Non-sterile | Equivalent |
| Shelf Life | 2 years | 2 years | Equivalent |

## 7. SUBSTANITAL EQUIVALENCE

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## 8. SUBSTANTIAL EQUIVALENCE DISCUSSION

The modified device is same to the cleared device in terms of description and indications for use. All of the technical characteristics are substantially equivalent to the corresponding characteristics of the cleared device. There might be slight differences in the weight of raw materials between the modified device and cleared device, however, the chemical composition is same and the data of non-clinical testing such as performance and biological testing provided in this submission proves substantial equivalence to the cleared device in safety and performance.

Therefore, the performance and biocompatibility testing performed demonstrates that any differences in their technological characteristics do not raise any new questions as to safety and effectiveness. Hence, it is concluded that it is substantially equivalent to the cleared devices.