Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a chemical root canal sealer and its physical and biological properties, with no mention of AI or ML.

Therapeutic

Yes
This device, a root canal sealer, is used for permanent root canal obturation, which involves treating a disease or condition (e.g., infected root canal) by filling the canal to prevent re-infection, thereby restoring the tooth's function and health. This falls under the definition of a therapeutic device.

Diagnostic

No
The device is described as a "root canal sealer" used for "Permanent root canal obturation." Its purpose is to physically fill and seal the root canal, not to identify or diagnose a condition. The performance studies and key metrics relate to material properties (e.g., setting time, flow, solubility) relevant to its function as a sealer, not to diagnostic accuracy.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "pre-loaded syringe type" and a "root canal sealer conforming to ISO 6876," which are physical components and a material, not software. The performance studies also focus on physical and biological properties of the material.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is "Permanent root canal obturation." This is a procedure performed within the body (in the root canal of a tooth) to seal it.
Device Description: The device is a root canal sealer that sets by absorbing moisture around the root canal. This further confirms its use within the body.
Lack of Diagnostic Purpose: IVDs are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform any such diagnostic function. It is a therapeutic device used to seal a root canal.

The information provided clearly indicates this is a medical device used for a dental procedure, not an in vitro diagnostic test.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Permanent root canal obturation

Product codes (comma separated list FDA assigned to the subject device)

KIF

Device Description

This product is the root canal sealer conforming to ISO 6876. This is a pre-loaded syringe type that does not require mixing and set by absorbing the moisture around the root canal.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

root canal

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Dental professional

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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)

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K170175

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 872.3820 Root canal filling resin.

(a)
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.(b)
Classification. (1) Class II if chloroform is not used as an ingredient in the device.(2) Class III if chloroform is used as an ingredient in the device.
(c)
Date PMA or notice of completion of a PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before December 26, 1996 for any root canal filling resin described in paragraph (b)(2) of this section that was in commercial distribution before May 28, 1976, or that has, on or before December 26, 1996 been found to be substantially equivalent to a root canal filling resin described in paragraph (b)(2) of this section that was in commercial distribution before May 28, 1976. Any other root canal filling resin shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.

Summary

0

Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is 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.

March 24, 2021

Maruchi Sung Jang CEO 2-208, Medical Industry Complex Bldg., 42-10, Taejanggongdan-gil Wonju-si, Gangwon-do 26311 REPUBLIC OF KOREA

Re: K202015

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: January 15, 2021 Received: January 27, 2021

Dear Sung Jang:

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 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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 Ouality 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 | | | Form Approved: Expiration Date: 06/30/2023 | | | | | |
|-------------------------------------------------------------------------| | | 510(k) Number (if known) | | ---------------------|--|-----------------------------------------------------------------|--|--------------------------|--|--|--|
| Indications for Use | | | | See PRA Statement below. | | | |
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Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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FORM FDA 3881 (6/20)

Page 1 of 1

PSC Publishing Services (301) 443-6740 EF

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K202015

510(k) Summary

Date: August 20, 2020

1. SUBMITTER

MARUCHI

2-208, Medical Industry Complex Bldg., 42-10, Taejanggongdan-gil, Wonju-si, Gangwon-do, 26311, Republic of Korea TEL : +82-33-734-0330

FAX : +82-33-746-2804 Contact Name: Sung Wook, Jang Email: ra@endocem.com

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. PREDICATE DEVICE

K170175, ENDOSEAL MTA, MARUCHI

4. DEVICE DESCRIPTION

This product is the root canal sealer conforming to ISO 6876. This is a pre-loaded syringe type that does not require mixing and set by absorbing the moisture around the root canal.

5. INDICATIONS FOR USE

Permanent root canal obturation

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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)

	Proposed Device	Predicate Device	Discuss/Justify the Differences
510(k) Number	K202015	K170175	-
Trade Name	White ENDOSEAL MTA	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	This product is the root canal sealer conforming to ISO 6876. This is a pre-loaded syringe type that does not require mixing and set by absorbing the	ENDOSEAL MTA is an endodontic sealer based on MTA, providing a root canal filling. It is premixed and pre-loaded in a syringe, which allows a complete	Equivalent
	moisture around the root canal.	filling of the entire root canal including accessory and lateral canals.
Indications for Use	Permanent root canal obturation	* 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. | Equivalent |
| Intended user | Dental professional | Dental professional | Equivalent |
| Standards | ISO 6876 | ISO 6876 | Equivalent |
| Physical properties | Setting time: 29 min
Flow: 22 mm
Radiopacity: 7.7 mm
Flim thickness: 14 μm
Solubility: 0.3 % | Setting time: 12.31 min
Flow: 21 mm
Radiopacity: 10.14 mm
Flim thickness: 15 μm
Solubility: 0.7 % | Differences |
| Chemical Composition | -Zirconium dioxide
-Dimethyl sulfoxide
-Calcium silicate
(Tricalcium silicate)
-Water
-Bentonite Clay
-Polyvinyl alcohol
-Polyvinyl pyrrolidone
-Lithium Carbonate | -Natural Pure Cement
-Zirconium dioxide
-Bismuth trioxide
-Bentonite Clay
-n-Methyl-2-Pyrrolidone
-Hypromellose | Differences |
| 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

White ENDOSEAL MTA has the same Indications for Use and the principle of operations as the predicate devices. It is intended purpose as they are placed into the root canal as a root filling materials which met the requirement according to ISO 6876. It has similar physical and biocompatible properties and demonstrates comparable performance specifications to the predicate devices.

The chemical compositions might slightly different from the predicate devices, both are used calcium silicate as base material, and additional components are used to improve flowability.

The bench and biocompatibility testing performed demonstrates that any differences in their technological characteristics do not raise any new questions as to safety and effectiveness. Therefore, it is concluded that White ENDOSEAL MTA is substantially equivalent to the predicate devices. Hence, its equivalent is acceptable.