K Number

Device Name

Endocem MTA Premixed Regular

Manufacturer

Maruchi

Date Cleared

2023-02-14

(441 days)

Product Code

KIF

Regulation Number

872.3820

Intended Use

The product is used for indirect pulp capping, direct pulp capping, root end filling and Repair of perforation.

Device Description

ENDOCEM MTA PREMIXED REGULAR is a root canal filling material 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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K082943, K102867

Reference Devices

K102867

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a material used for dental procedures and does not mention any computational or analytical capabilities that would suggest the use of AI or ML.

Therapeutic

Yes
The device is used for medical repair procedures within the root canal, such as pulp capping and root end filling, which are therapeutic interventions.

Diagnostic

No
The device, ENDOCEM MTA PREMIXED REGULAR, is described as a root canal filling material. Its intended uses (indirect pulp capping, direct pulp capping, root end filling, and repair of perforation) are all related to treatment and repair of dental issues, not diagnosis. The performance studies also focus on material properties and biocompatibility, not diagnostic accuracy.

SaMD (Software as a Medical Device)

The device description clearly states it is a "root canal filling material conforming to ISO 6876, in a pre-loaded syringe". This describes a physical material and delivery system, not software.

IVD (In Vitro Diagnostic)

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

Here's why:

IVDs are used to examine specimens from the human body. The intended use of this device is for dental procedures within the root canal, directly on the patient's tooth structure. It's a material used for filling and repairing, not for analyzing biological samples.
The device description and intended use clearly indicate a therapeutic/restorative purpose. It's a root canal filling material used for procedures like pulp capping and repair of perforations.
The performance studies focus on material properties and biocompatibility. The tests mentioned (setting time, solubility, radioopacity, cytotoxicity, sensitization, systemic toxicity, genotoxicity) are typical for dental materials that are placed within the body, not for diagnostic tests.

Therefore, this device falls under the category of a dental material used for treatment, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The product is used for indirect pulp capping, direct pulp capping, root end filling and Repair of perforation.

Product codes

KIF

Device Description

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

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

Testing institution's method Visual, Volume test, Setting time, pH .
ISO 6876 - Package, Extraneous matter, Setting time, Solubility, Radioopacity
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

Not Found

Predicate Device(s)

K082943, K102867

Reference Device(s)

K102867

Predetermined Change Control Plan (PCCP) - All Relevant Information

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

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.

February 14, 2023

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

Re: K213757

Trade/Device Name: Endocem MTA Premixed Regular Regulation Number: 21 CFR 872.3820 Regulation Name: Root Canal Filling Resin Regulatory Class: Class II Product Code: KIF Dated: May 20, 2022 Received: May 26, 2022

Dear Sungwook 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.

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 -S

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 Ouality Center for Devices and Radiological Health

Enclosure

Indications for Use

510(k) Number (if known) K213757

Device Name ENDOCEM MTA PREMIXED REGULAR

Indications for Use (Describe)

The product is used for indirect pulp capping, direct pulp capping, root end filling and Repair of perforation.

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/1 description: The image contains the logo for Maruchi. The logo consists of a stylized flower-like graphic on the left and the word "MARUCHI" in a sans-serif font on the right. The flower graphic is multi-colored, with petals in shades of blue, green, purple, pink, and orange. The word "MARUCHI" is in a dark gray or black color.

510(k) Summary

Date: February 13, 2023

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: ENDOCEM MTA PREMIXED REGULAR ·Common Name: Root Filling Material · Classification Name: Resin, Root canal filling · Regulation Number 872.3820 ·Class: 2 ·Classification Product Code: KIF

3. PREDICATE DEVICE

K082943, iRoot BP Injectable Root Canal Repair Filling Material, Innovative BioCeramix Inc

K102867, iRoot FS, Innovative BioCeramix Inc

4. DEVICE DESCRIPTION

5. INDICATIONS FOR USE

The product is used for indirect pulp capping, direct pulp capping, root end filling and

Image /page/4/Picture/0 description: The image contains the logo for Maruchi. The logo consists of a colorful, stylized flower-like design with rounded petals in shades of blue, green, purple, and pink. To the right of the floral design is the word "MARUCHI" in bold, black sans-serif letters. The overall design is clean and modern.

Repair of perforation.

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 Visual, Volume test, Setting time, pH .
ISO 6876 - Package, Extraneous matter, Setting time, Solubility, Radioopacity
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	Reference Device	Discuss/Justify the Differences
510(k) Number	New	K082943	K102867	-
Trade Name	ENDOCEM MTA
PREMIXED
REGULAR	iRoot BP Injectable
Root Canal Repair
Filling Material	iRoot FS	-
Manufacturer	MARUCHI	Innovative
BioCeramix Inc	Innovative
BioCeramix Inc	-
Common Name	Root Filling
Material	Root Filling Material	Root Filling Material	Equivalent
Classification
Name	Resin, Root canal filling	Resin, Root canal filling	Resin, Root canal filling	Equivalent
Device Class	2	2	2	Equivalent
Product Code	KIF	KIF	KIF	Equivalent
Device
Description	ENDOCEM MTA
PREMIXED
REGULAR is a
root canal filling
material
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.	iRoot BP Injectable
Root Canal Repair
Filling Material
(iRoot BP) is a
convenient ready-to-
use white hydraulic
premixed injectable
BioAggregate paste
developed for
permanent root canal
repair and filling
applications. iRoot
BP is an insoluble,
radiopaque and
aluminum-free
material based on a
calcium silicate
composition, which
requires the presence
of water to set and
harden. iRoot BP
does not shrink
during setting and
demonstrates
excellent physical
properties. iRoot BP
is packaged in a
preloaded syringe
and is supplied with
disposable tips.	iRoot FS Fast Set
Root Repair Material
(iRoot FS) is a
convenient ready-to-
use fast setting white
hydraulic premixed
bioceramic paste
developed for
permanent root canal
repair of root
perforation and
root canal resorption,
and root end filling,
apexification and
pulp capping
applications. iRoot
FS is an insoluble,
radiopaque and
aluminum-free
material based on a
calcium silicate
composition, which
requires the presence
of water to set and
harden. iRoot FS
does not shrink
during setting and
demonstrates
excellent physical
properties. iRoot FS
is available as a
Indications for
Use	The product is used
for indirect pulp
capping, direct pulp
capping, root end
filling and Repair
of perforation.	Repair of Root
Perforation
Repair of Root
Resorption
Root End Filling
Apexification
Pulp Capping	preloaded syringe
with disposable tips
and a preloaded
container.
Repair of Root
Perforation
Repair of Root
Resorption
Root End Filling
Apexification
Pulp Capping	Equivalent
Intended user	Dental professional	Dental professional	Dental professional	Equivalent
Standards	ISO 6876	ISO 6876	ISO 6876	Equivalent
Setting times	4.2 min	Minimum of 2 hours	Approximately 20
minutes	Differences
Chemical
Composition	Zirconium dioxide
Calcium silicate
DMSO
(Dimethylsulfoxide
)
Calcium aluminate
Calcium sulfate
Bentonite
Hydroxypropyl
Methyl Cellulose
Silica
Lithium carbonate
Water
Ethanol	Zirconium oxide
Calcium silicates
Tantalum pentoxide
Calcium phosphate
monobasic and filler
agents.	Zirconium oxide
Dicalcium silicate
Tantalum pentoxide
Tricalcium silicate
Calcium Sulfate and
filler agents	Differences
Liquid Formula	Paste type	Paste type	Paste type	Equivalent
Packaging	Pre-loaded syringe	Pre-loaded syringe	Pre-loaded syringe	Equivalent
Sterile	Non-sterile	Non-sterile	Non-sterile	Equivalent
Shelf Life	2 years	2 years	2 years	Equivalent

7. SUBSTANITAL EQUIVALENCE

Image /page/5/Picture/0 description: The image shows the Maruchi logo. The logo consists of a colorful flower-like graphic on the left and the word "MARUCHI" in black, sans-serif font on the right. The graphic has petals in shades of blue, green, pink, and yellow.

Image /page/6/Picture/0 description: The image contains the Maruchi logo. The logo consists of a colorful flower-like graphic on the left and the word "MARUCHI" in a simple, sans-serif font on the right. The flower graphic has multiple petals in different colors, including blue, green, pink, and purple.

Image /page/7/Picture/0 description: The image shows the logo for Maruchi. The logo consists of a colorful flower-like graphic on the left and the word "MARUCHI" in a sans-serif font on the right. The graphic is made up of several petals in different colors, including blue, green, purple, and pink.

8. SUBSTANTIAL EQUIVALENCE DISCUSSION

ENDOCEM MTA PREMIXED REGULAR has the same Indications for Use and the principle of operations as the predicate device and reference device. 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 ENDOCEM MTA PREMIXED REGULAR is substantially equivalent to the predicate devices. Hence, its equivalent is acceptable.